{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2014-N-0297\" sorted by posted_date descending", "rows": [["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, null, null, "2017-01-06T15:31:12Z", null, 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, null, null, "2017-01-06T15:31:48Z", null, 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, null, null, "2017-01-06T15:32:33Z", null, 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, null, null, "2017-01-06T15:31:22Z", null, 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, null, null, "2017-01-06T15:30:18Z", null, 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, null, null, "2017-01-06T15:32:52Z", null, 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, null, null, "2017-01-06T15:32:01Z", null, 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, null, null, "2017-01-06T15:32:18Z", null, 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, null, null, "2017-01-06T15:28:53Z", null, 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, null, null, "2017-01-06T15:28:47Z", null, 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, null, null, "2017-01-06T15:28:59Z", null, 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, null, null, "2017-01-06T15:32:27Z", null, 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, null, null, "2017-01-06T15:32:43Z", null, 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, null, null, "2017-01-06T15:33:02Z", null, 0, 0, "090000648244d517"], ["FDA-2014-N-0297-0057", "FDA", "FDA-2014-N-0297", "Obstetrical and Gynecological Devices; Reclassification of Surgical\nInstrumentation for Use With Urogynecologic Surgical Mesh", "Rule", "Final Rule", "2017-01-06T05:00:00Z", 2017, 1, "2017-01-06T05:00:00Z", null, "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, null, null, "2017-01-06T15:31:02Z", null, 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, null, null, "2017-01-06T15:31:55Z", null, 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, null, null, "2017-01-06T15:32:11Z", null, 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, null, null, "2017-01-06T15:31:40Z", null, 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, null, null, "2017-01-06T15:32:38Z", null, 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, null, null, "2017-01-06T15:33:08Z", null, 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, null, null, "2017-01-06T15:29:41Z", null, 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, null, null, "2017-01-06T15:29:10Z", null, 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, null, null, "2017-01-06T15:29:25Z", null, 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, null, null, "2017-01-06T15:31:07Z", null, 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, null, null, "2017-01-06T15:31:17Z", null, 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, null, null, "2017-01-06T15:30:49Z", null, 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, null, null, "2017-01-06T15:29:15Z", null, 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, null, null, "2017-01-06T15:30:53Z", null, 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, null, null, "2017-01-06T15:29:57Z", null, 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, null, null, "2017-01-06T15:30:28Z", null, 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, null, null, "2017-01-06T15:33:13Z", null, 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, null, null, "2017-01-06T15:32:06Z", null, 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, null, null, "2017-01-06T15:32:23Z", null, 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, null, null, "2017-01-06T15:30:23Z", null, 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, null, null, "2017-01-06T15:32:57Z", null, 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, null, null, "2017-01-06T15:29:48Z", null, 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, null, null, "2017-01-06T15:29:20Z", null, 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\nInstrumentation for Use With Urogynecologic Surgical Mesh", "Supporting & Related Material", "Background Material", "2017-01-06T05:00:00Z", 2017, 1, null, null, "2017-01-06T15:28:17Z", null, 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, null, null, "2017-01-06T15:28:41Z", null, 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, null, null, "2017-01-06T15:29:05Z", null, 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, null, null, "2017-01-06T15:29:30Z", null, 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, null, null, "2017-01-06T15:29:36Z", null, 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, null, null, "2017-01-06T15:31:33Z", null, 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, null, null, "2017-01-06T15:30:35Z", null, 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, null, null, "2017-01-06T15:31:26Z", null, 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, null, null, "2017-01-06T15:29:52Z", null, 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, null, null, "2017-01-06T15:30:03Z", null, 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, null, null, "2017-01-06T15:32:48Z", null, 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, null, null, "2016-01-06T14:24:39Z", null, 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, null, null, "2016-01-06T14:26:22Z", null, 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, null, null, "2016-01-06T14:24:11Z", null, 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, null, null, "2016-01-06T14:24:45Z", null, 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, null, null, "2016-01-06T14:24:50Z", null, 0, 0, "0900006481de94b3"], ["FDA-2014-N-0297-0049", "FDA", "FDA-2014-N-0297", "Reference 25, Rapp DE, King AB, Rowe B, Wolters JP. 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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, null, null, "2016-01-06T14:26:48Z", null, 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, null, null, "2016-01-06T14:27:23Z", null, 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, null, null, "2016-01-06T14:25:17Z", null, 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, null, null, "2016-01-06T14:26:16Z", null, 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, null, null, "2016-01-06T14:26:27Z", null, 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, null, null, "2016-01-06T14:26:42Z", null, 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, null, null, "2016-01-06T14:27:39Z", null, 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, null, null, "2016-01-06T14:23:58Z", null, 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, null, null, "2016-01-06T14:24:32Z", null, 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, null, null, "2016-01-06T14:24:56Z", null, 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, null, null, "2016-01-06T14:25:36Z", null, 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, null, null, "2016-01-06T14:27:06Z", null, 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, null, null, "2016-01-06T14:27:11Z", null, 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, null, null, "2016-01-06T14:25:46Z", null, 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, null, null, "2016-01-06T14:26:10Z", null, 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, null, null, "2016-01-06T14:26:35Z", null, 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. 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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, null, null, "2016-01-06T14:25:30Z", null, 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, null, null, "2016-01-06T14:26:04Z", null, 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, null, null, "2016-01-06T14:26:54Z", null, 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, null, null, "2016-01-06T14:24:04Z", null, 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, null, null, "2016-01-06T14:25:52Z", null, 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, null, null, "2016-01-06T14:27:17Z", null, 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, null, null, "2016-01-06T14:25:05Z", null, 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, null, null, "2016-01-06T14:27:46Z", null, 0, 0, "0900006481dece43"], ["FDA-2014-N-0297-0022", "FDA", "FDA-2014-N-0297", "Obstetrical and Gynecological Devices; Reclassification of Surgical\nMesh for Transvaginal Pelvic Organ Prolapse Repair", "Rule", "Final Rule", "2016-01-05T05:00:00Z", 2016, 1, "2016-01-05T05:00:00Z", null, "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, null, null, "2016-03-22T18:28:28Z", null, 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", null, "2014-07-14T17:23:35Z", null, 0, 0, "09000064817ab53f"], ["FDA-2014-N-0297-0001", "FDA", "FDA-2014-N-0297", "Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse\nRepair and Surgical Instrumentation for Urogynecologic Surgical Mesh\nProcedures; 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