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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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