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| id | agency_id | docket_id | title | document_type | subtype | posted_date ▲ | posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA-2014-N-0297-0083 | FDA | None FDA-2014-N-0297 | Reference 12 (2017 FO), Hiltunen et al., Low-Weight Polyprophoylene Mesh for Anterior re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:12Z | 0 | 0 | 090000648244d37d | |||
| FDA-2014-N-0297-0089 | FDA | None FDA-2014-N-0297 | Reference 15, Abed et al. Int Urogynecol. 2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:48Z | 0 | 0 | 090000648244d383 | |||
| FDA-2014-N-0297-0097 | FDA | None FDA-2014-N-0297 | Reference 23, Stanford EJ, Moore RD, Roovers JP et al. Elevate anterior-apical-12-month data showing safety and efficacy in surgical treatment...2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:33Z | 0 | 0 | 090000648244d38f | |||
| FDA-2014-N-0297-0085 | FDA | None FDA-2014-N-0297 | Reference 13 & 32, Pelvic Florr Disorders Registery re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:22Z | 0 | 0 | 090000648244d37f | |||
| FDA-2014-N-0297-0075 | FDA | None FDA-2014-N-0297 | Reference 7, Armitage S, Seman EI, Keirse MJ. Use of surgisis for treatment of anterior and posterior vaginal prolapse. Obstet Gynecol Int. 2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:30:18Z | 0 | 0 | 090000648244d503 | |||
| FDA-2014-N-0297-0101 | FDA | None FDA-2014-N-0297 | Reference 27, Moore RD, Mitchell GK, Miklos JR. Single-incision vaginal approach to treat cystocele and vault prolapse with an anteriory...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:52Z | 0 | 0 | 090000648244d515 | |||
| FDA-2014-N-0297-0091 | FDA | None FDA-2014-N-0297 | Reference 17, Onwude JL. Genital prolapse in women. Clin Evid (Online) 2012 Mar 14 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:01Z | 0 | 0 | 090000648244d387 | |||
| FDA-2014-N-0297-0094 | FDA | None FDA-2014-N-0297 | Reference 20, Barski D, Otto T, Gerullis H. Systematic review and classification of complications after anterior, posterior, apical, and total vaginal mesh...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:18Z | 0 | 0 | 090000648244d38a | |||
| FDA-2014-N-0297-0061 | FDA | None FDA-2014-N-0297 | Reference 1,Ob Gyn Panel Meeting Transcript. Sept 9 2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:28:53Z | 0 | 0 | 090000648244d36a | |||
| FDA-2014-N-0297-0060 | FDA | None FDA-2014-N-0297 | Reference 1,Ob Gyn Panel Meeting Transcript. Sept 8 2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:28:47Z | 0 | 0 | 090000648244d369 | |||
| FDA-2014-N-0297-0062 | FDA | None FDA-2014-N-0297 | Reference 2(2017 FO), Urogyn Mesh Instrumentation Panel Meeting - FDA Presentation re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:28:59Z | 0 | 0 | 090000648244d36b | |||
| FDA-2014-N-0297-0096 | FDA | None FDA-2014-N-0297 | Reference 22, Azais H, Charles CJ, Delporte P, Debondinance P. Prolapse repair using the Elevate kit...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:27Z | 0 | 0 | 090000648244d38e | |||
| FDA-2014-N-0297-0099 | FDA | None FDA-2014-N-0297 | Reference 25, Rapp DE, King AB, Rowe B, Wolters JP. Comprehensive evaluation of Anterior Elevate System in the treatment of anterior...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:43Z | 0 | 0 | 090000648244d513 | |||
| FDA-2014-N-0297-0103 | FDA | None FDA-2014-N-0297 | Reference 29, Sirls LT, McLennan GP, Killinger KA et al 2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:33:02Z | 0 | 0 | 090000648244d517 | |||
| FDA-2014-N-0297-0057 | FDA | None FDA-2014-N-0297 | Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Rule | Final Rule | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T05:00:00Z | 2017-01-06T15:07:58Z | 2016-31862 | 0 | 0 | 090000648244e8c4 | |
| FDA-2014-N-0297-0081 | FDA | None FDA-2014-N-0297 | Reference 11(2017 FO), Sung et al., Graft Use in Trasvaginal Pelvic Organ Prolapse and Urinary Incontinence re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:02Z | 0 | 0 | 090000648244d37b | |||
| FDA-2014-N-0297-0090 | FDA | None FDA-2014-N-0297 | Reference 16 (PMA), Safety Communications _ UPDATE on Serious Complications Associated with Tran re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:55Z | 0 | 0 | 090000648244d386 | |||
| FDA-2014-N-0297-0093 | FDA | None FDA-2014-N-0297 | Reference 19, Maher et al. Cochrane Database Syst Review. 2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:11Z | 0 | 0 | 090000648244d389 | |||
| FDA-2014-N-0297-0088 | FDA | None FDA-2014-N-0297 | Reference 14, Geoffrion R, Murphy M, Robert M. Vaginal paravaginal repair with porcine small intestine submucosa- midterm outcomes...2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:40Z | 0 | 0 | 090000648244d382 | |||
| FDA-2014-N-0297-0098 | FDA | None FDA-2014-N-0297 | Reference 24, Lubkan J, Roovers JP, Vandrie DM et al. Single-incision apical and posterior mesh repair...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:38Z | 0 | 0 | 090000648244d512 | |||
| FDA-2014-N-0297-0104 | FDA | None FDA-2014-N-0297 | Reference 30, Sinhal D, Iyer J, Mous M et al. Anterior-apical mesh repair system in an ambulatory setting. Ambulatory Surg 2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:33:08Z | 0 | 0 | 090000648244d518 | |||
| FDA-2014-N-0297-0070 | FDA | None FDA-2014-N-0297 | Reference 5(2017 FO), Maher et al., Surgical Management of Pelvic Organ Prolapse in Women re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:41Z | 0 | 0 | 090000648244d0fe | |||
| FDA-2014-N-0297-0064 | FDA | None FDA-2014-N-0297 | Reference 2(2017 FO), Urogyn Mesh Instrumentation Panel Meeting - FDA Presentation re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:10Z | 0 | 0 | 090000648244d36d | |||
| FDA-2014-N-0297-0067 | FDA | None FDA-2014-N-0297 | Reference 3(2017 FO),Transcript of the February 26, 2016, meeting of the Gastroenterology-Urology Devices Panel re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:25Z | 0 | 0 | 090000648244d370 | |||
| FDA-2014-N-0297-0082 | FDA | None FDA-2014-N-0297 | Reference 11, Robert M, Girard I, Brennand E et al. Absorbable mesh augmentation...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:07Z | 0 | 0 | 090000648244d37c | |||
| FDA-2014-N-0297-0084 | FDA | None FDA-2014-N-0297 | Reference 12, Sung V, Rardin C, Raker C et al. Porcine subintestinal submucosal graft augmentation for rectocele repair. Obstet Gynecol 2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:17Z | 0 | 0 | 090000648244d37e | |||
| FDA-2014-N-0297-0079 | FDA | None FDA-2014-N-0297 | Reference 10 (2017 FO), Withagen et al., Trocar-Guided Mesh Compared With Conventional Mesh Repair re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:30:49Z | 0 | 0 | 090000648244d507 | |||
| FDA-2014-N-0297-0065 | FDA | None FDA-2014-N-0297 | Reference 2, Deprest J-de Ridder D-Roovers JP et al. Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts. J Urol 2009 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:15Z | 0 | 0 | 090000648244d36e | |||
| FDA-2014-N-0297-0080 | FDA | None FDA-2014-N-0297 | Reference 10, Feldner PC, Castro RA, Cipolotti LA et al. anterior vaginal wall prolapse...2010 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:30:53Z | 0 | 0 | 090000648244d37a | |||
| FDA-2014-N-0297-0073 | FDA | None FDA-2014-N-0297 | Reference 6, Mouritsen L, Kronschnabl M, Lose G. Long-term results of vaginal repairs ... Int Urogynecol J Pelvic Floor Dysfunct 2010 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:57Z | 0 | 0 | 090000648244d501 | |||
| FDA-2014-N-0297-0077 | FDA | None FDA-2014-N-0297 | Reference 9 (2017 FO), Vaginal Mesh for Prolapse A Randomized Controlled Trial re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:30:28Z | 0 | 0 | 090000648244d505 | |||
| FDA-2014-N-0297-0105 | FDA | None FDA-2014-N-0297 | Reference 31, Brennand EA, Bhayana D, Tang S et al. Anchor placement and subsequent movement in a mesh kit...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:33:13Z | 0 | 0 | 090000648244d519 | |||
| FDA-2014-N-0297-0092 | FDA | None FDA-2014-N-0297 | Reference 18, Maher C. Anterior vaginal compartment surgery. Int Urogynecol J 2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:06Z | 0 | 0 | 090000648244d388 | |||
| FDA-2014-N-0297-0095 | FDA | None FDA-2014-N-0297 | Reference 21, Su TH, Lau HH, Huang WC et al. Single-incision mesh repair versus traditional native tissue repair...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:23Z | 0 | 0 | 090000648244d38d | |||
| FDA-2014-N-0297-0076 | FDA | None FDA-2014-N-0297 | Reference 8(2017 FO), Altman et al., Anterior Colporrhaphy Versus Transvagibal Mesh for Pelvic-Organ re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:30:23Z | 0 | 0 | 090000648244d504 | |||
| FDA-2014-N-0297-0102 | FDA | None FDA-2014-N-0297 | Reference 28, Gustapane S, Leombroni M, Falo E et al. Surgical repair of pelvic organ prolapse and follow-up...2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:57Z | 0 | 0 | 090000648244d516 | |||
| FDA-2014-N-0297-0071 | FDA | None FDA-2014-N-0297 | Reference 5, Reid RI, Luo K. Site-specific prolapse surgery...2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:48Z | 0 | 0 | 090000648244d0ff | |||
| FDA-2014-N-0297-0066 | FDA | None FDA-2014-N-0297 | Reference 3 & 8, Jeffery ST and Nieuwoudt A. Beyond the complications...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:20Z | 0 | 0 | 090000648244d36f | |||
| FDA-2014-N-0297-0058 | FDA | None FDA-2014-N-0297 | List of References_FDA-2014-N-0297_Reclassification of Surgical Mesh Final Order re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:28:17Z | 0 | 0 | 090000648244d0af | |||
| FDA-2014-N-0297-0059 | FDA | None FDA-2014-N-0297 | Reference 1 (2017 FO), FDA Exec Summ - Reclass of Urogyno Surg Mesh Instru Feb, 26, 2016 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:28:41Z | 0 | 0 | 090000648244d0b0 | |||
| FDA-2014-N-0297-0063 | FDA | None FDA-2014-N-0297 | Reference 2, Deprest J-de Ridder D-Roovers JP et al. Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts. J Urol 2009 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:05Z | 0 | 0 | 090000648244d36c | |||
| FDA-2014-N-0297-0068 | FDA | None FDA-2014-N-0297 | Reference 4(2017 FO), Caquant et al., Safety of Trans Vaginal Mesh Procedure re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:30Z | 0 | 0 | 090000648244d371 | |||
| FDA-2014-N-0297-0069 | FDA | None FDA-2014-N-0297 | Reference 4, Ellis CN. Outcomes after the repair of rectoceles with transperineal insertion of a bioprosthetic graft. Dis Colon Rectum 2010 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:36Z | 0 | 0 | 090000648244d372 | |||
| FDA-2014-N-0297-0087 | FDA | None FDA-2014-N-0297 | Reference 14 (2017 FO), Sivaslioglu et al., A Randomized Comparison of Polyproylene Mesh Surgery re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:33Z | 0 | 0 | 090000648244d381 | |||
| FDA-2014-N-0297-0078 | FDA | None FDA-2014-N-0297 | Reference 9, Madhu C, Cooke J, Harber P, Holmes D. Functional outcomes of posterior vaginal wall repair and prespinous...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:30:35Z | 0 | 0 | 090000648244d506 | |||
| FDA-2014-N-0297-0086 | FDA | None FDA-2014-N-0297 | Reference 13 (2017 FO), Jia et al., Efficacy and Safety of Using Mesh or Grafts re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:31:26Z | 0 | 0 | 090000648244d380 | |||
| FDA-2014-N-0297-0072 | FDA | None FDA-2014-N-0297 | Reference 6(2017 FO), Diwadkar et al., Complication and Reproduction Rates After Apical Vaginal re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:29:52Z | 0 | 0 | 090000648244d500 | |||
| FDA-2014-N-0297-0074 | FDA | None FDA-2014-N-0297 | Reference 7(2017 FO), Maher et al., Laparoscopic Sacral Colpopexy Versus Total Vaginal Mesh for Vaginal re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:30:03Z | 0 | 0 | 090000648244d502 | |||
| FDA-2014-N-0297-0100 | FDA | None FDA-2014-N-0297 | Reference 26, Wong V, Shek KL, Rane A et al. A comparison of two different mesh kit systems for anterior compartment prolapse repair 2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh | Supporting & Related Material | Background Material | 2017-01-06T05:00:00Z | 2017 | 1 | 2017-01-06T15:32:48Z | 0 | 0 | 090000648244d514 | |||
| FDA-2014-N-0297-0028 | FDA | None FDA-2014-N-0297 | Reference 4, Ellis CN. Outcomes after the repair of rectoceles with transperineal insertion of a bioprosthetic graft. Dis Colon Rectum 2010 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:24:39Z | 0 | 0 | 0900006481de94b1 | |||
| FDA-2014-N-0297-0043 | FDA | None FDA-2014-N-0297 | Reference 19, Maher et al. Cochrane Database Syst Review. 2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:22Z | 0 | 0 | 0900006481de94c0 | |||
| FDA-2014-N-0297-0025 | FDA | None FDA-2014-N-0297 | Reference 1-a, Ob Gyn Panel Meeting Transcript. Sept 9 2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:24:11Z | 0 | 0 | 0900006481de9490 | |||
| FDA-2014-N-0297-0029 | FDA | None FDA-2014-N-0297 | Reference 5, Reid RI, Luo K. Site-specific prolapse surgery...2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:24:45Z | 0 | 0 | 0900006481de94b2 | |||
| FDA-2014-N-0297-0030 | FDA | None FDA-2014-N-0297 | Reference 6, Mouritsen L, Kronschnabl M, Lose G. Long-term results of vaginal repairs ... Int Urogynecol J Pelvic Floor Dysfunct 2010 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:24:50Z | 0 | 0 | 0900006481de94b3 | |||
| FDA-2014-N-0297-0049 | FDA | None FDA-2014-N-0297 | Reference 25, Rapp DE, King AB, Rowe B, Wolters JP. Comprehensive evaluation of Anterior Elevate System in the treatment of anterior...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:27:00Z | 0 | 0 | 0900006481de94c6 | |||
| FDA-2014-N-0297-0026 | FDA | None FDA-2014-N-0297 | Reference 2, Deprest J-de Ridder D-Roovers JP et al. Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts. J Urol 2009 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:24:17Z | 0 | 0 | 0900006481de9491 | |||
| FDA-2014-N-0297-0034 | FDA | None FDA-2014-N-0297 | Reference 10, Feldner PC, Castro RA, Cipolotti LA et al. anterior vaginal wall prolapse...2010 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:25:23Z | 0 | 0 | 0900006481de94b6 | |||
| FDA-2014-N-0297-0039 | FDA | None FDA-2014-N-0297 | Reference 15, Abed et al. Int Urogynecol. 2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:25:58Z | 0 | 0 | 0900006481de94bc | |||
| FDA-2014-N-0297-0047 | FDA | None FDA-2014-N-0297 | Reference 23, Stanford EJ, Moore RD, Roovers JP et al. Elevate anterior-apical-12-month data showing safety and efficacy in surgical treatment...2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:48Z | 0 | 0 | 0900006481de94c4 | |||
| FDA-2014-N-0297-0053 | FDA | None FDA-2014-N-0297 | Reference 29, Sirls LT, McLennan GP, Killinger KA et al 2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:27:23Z | 0 | 0 | 0900006481de94ca | |||
| FDA-2014-N-0297-0033 | FDA | None FDA-2014-N-0297 | Reference 9, Madhu C, Cooke J, Harber P, Holmes D. Functional outcomes of posterior vaginal wall repair and prespinous...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:25:17Z | 0 | 0 | 0900006481de94b5 | |||
| FDA-2014-N-0297-0042 | FDA | None FDA-2014-N-0297 | Reference 18, Maher C. Anterior vaginal compartment surgery. Int Urogynecol J 2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:16Z | 0 | 0 | 0900006481de94bf | |||
| FDA-2014-N-0297-0044 | FDA | None FDA-2014-N-0297 | Reference 20, Barski D, Otto T, Gerullis H. Systematic review and classification of complications after anterior, posterior, apical, and total vaginal mesh...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:27Z | 0 | 0 | 0900006481de94c1 | |||
| FDA-2014-N-0297-0046 | FDA | None FDA-2014-N-0297 | Reference 22, Azais H, Charles CJ, Delporte P, Debondinance P. Prolapse repair using the Elevate kit...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:42Z | 0 | 0 | 0900006481de94c3 | |||
| FDA-2014-N-0297-0055 | FDA | None FDA-2014-N-0297 | Reference 31, Brennand EA, Bhayana D, Tang S et al. Anchor placement and subsequent movement in a mesh kit...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:27:39Z | 0 | 0 | 0900006481de94cc | |||
| FDA-2014-N-0297-0023 | FDA | None FDA-2014-N-0297 | List of References re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:23:58Z | 0 | 0 | 0900006481de948e | |||
| FDA-2014-N-0297-0027 | FDA | None FDA-2014-N-0297 | Reference 3 & 8, Jeffery ST and Nieuwoudt A. Beyond the complications...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:24:32Z | 0 | 0 | 0900006481de9492 | |||
| FDA-2014-N-0297-0031 | FDA | None FDA-2014-N-0297 | Reference 7, Armitage S, Seman EI, Keirse MJ. Use of surgisis for treatment of anterior and posterior vaginal prolapse. Obstet Gynecol Int. 2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:24:56Z | 0 | 0 | 0900006481de94b4 | |||
| FDA-2014-N-0297-0036 | FDA | None FDA-2014-N-0297 | Reference 12, Sung V, Rardin C, Raker C et al. Porcine subintestinal submucosal graft augmentation for rectocele repair. Obstet Gynecol 2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:25:36Z | 0 | 0 | 0900006481de94b8 | |||
| FDA-2014-N-0297-0050 | FDA | None FDA-2014-N-0297 | Reference 26, Wong V, Shek KL, Rane A et al. A comparison of two different mesh kit systems for anterior compartment prolapse repair 2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:27:06Z | 0 | 0 | 0900006481de94c7 | |||
| FDA-2014-N-0297-0051 | FDA | None FDA-2014-N-0297 | Reference 27, Moore RD, Mitchell GK, Miklos JR. Single-incision vaginal approach to treat cystocele and vault prolapse with an anteriory...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:27:11Z | 0 | 0 | 0900006481de94c8 | |||
| FDA-2014-N-0297-0037 | FDA | None FDA-2014-N-0297 | Reference 13 & 32, Pelvic Florr Disorders Registery re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:25:46Z | 0 | 0 | 0900006481de94b9 | |||
| FDA-2014-N-0297-0041 | FDA | None FDA-2014-N-0297 | Reference 17, Onwude JL. Genital prolapse in women. Clin Evid (Online) 2012 Mar 14 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:10Z | 0 | 0 | 0900006481de94be | |||
| FDA-2014-N-0297-0045 | FDA | None FDA-2014-N-0297 | Reference 21, Su TH, Lau HH, Huang WC et al. Single-incision mesh repair versus traditional native tissue repair...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:35Z | 0 | 0 | 0900006481de94c2 | |||
| FDA-2014-N-0297-0054 | FDA | None FDA-2014-N-0297 | Reference 30, Sinhal D, Iyer J, Mous M et al. Anterior-apical mesh repair system in an ambulatory setting. Ambulatory Surg 2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:27:31Z | 0 | 0 | 0900006481de94cb | |||
| FDA-2014-N-0297-0035 | FDA | None FDA-2014-N-0297 | Reference 11, Robert M, Girard I, Brennand E et al. Absorbable mesh augmentation...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:25:30Z | 0 | 0 | 0900006481de94b7 | |||
| FDA-2014-N-0297-0040 | FDA | None FDA-2014-N-0297 | Reference 16 (PMA), Safety Communications _ UPDATE on Serious Complications Associated with Tran re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:04Z | 0 | 0 | 0900006481de94bd | |||
| FDA-2014-N-0297-0048 | FDA | None FDA-2014-N-0297 | Reference 24, Lubkan J, Roovers JP, Vandrie DM et al. Single-incision apical and posterior mesh repair...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:26:54Z | 0 | 0 | 0900006481de94c5 | |||
| FDA-2014-N-0297-0024 | FDA | None FDA-2014-N-0297 | Reference 1, Ob Gyn Panel Meeting Transcript. Sept 8 2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:24:04Z | 0 | 0 | 0900006481de948f | |||
| FDA-2014-N-0297-0038 | FDA | None FDA-2014-N-0297 | Reference 14, Geoffrion R, Murphy M, Robert M. Vaginal paravaginal repair with porcine small intestine submucosa- midterm outcomes...2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:25:52Z | 0 | 0 | 0900006481de94ba | |||
| FDA-2014-N-0297-0052 | FDA | None FDA-2014-N-0297 | Reference 28, Gustapane S, Leombroni M, Falo E et al. Surgical repair of pelvic organ prolapse and follow-up...2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:27:17Z | 0 | 0 | 0900006481de94c9 | |||
| FDA-2014-N-0297-0032 | FDA | None FDA-2014-N-0297 | Reference 8 Jeffery ST and Nieuwoudt A. Beyond the complications 2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:25:05Z | 0 | 0 | 0900006481dece42 | |||
| FDA-2014-N-0297-0056 | FDA | None FDA-2014-N-0297 | Reference 32, Pelvic Florr Disorders Registery re Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Supporting & Related Material | Background Material | 2016-01-06T05:00:00Z | 2016 | 1 | 2016-01-06T14:27:46Z | 0 | 0 | 0900006481dece43 | |||
| FDA-2014-N-0297-0022 | FDA | None FDA-2014-N-0297 | Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair | Rule | Final Rule | 2016-01-05T05:00:00Z | 2016 | 1 | 2016-01-05T05:00:00Z | 2016-01-05T14:47:59Z | 2015-33165 | 0 | 0 | 0900006481de89f4 | |
| FDA-2014-N-0297-0021 | FDA | None FDA-2014-N-0297 | Cited Materials re Comment from David Schmidt | Supporting & Related Material | Background Material | 2014-09-19T04:00:00Z | 2014 | 9 | 2016-03-22T18:28:28Z | 0 | 0 | 09000064817eb198 | |||
| FDA-2014-N-0297-0006 | FDA | None FDA-2014-N-0297 | Letter from FDA CDRH to AdvaMed | Other | Letter(s) | 2014-07-14T04:00:00Z | 2014 | 7 | 2014-07-14T04:00:00Z | 2014-07-14T17:23:35Z | 0 | 0 | 09000064817ab53f | ||
| FDA-2014-N-0297-0001 | FDA | None FDA-2014-N-0297 | Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2014-05-01T04:00:00Z | 2014 | 5 | 2014-05-01T04:00:00Z | 2014-07-31T03:59:59Z | 2014-08-01T01:03:51Z | 2014-09907 | 0 | 0 | 09000064816da464 |
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