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withdrawn,object_id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-0297-0028,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