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35 rows where docket_id = "FDA-2014-N-0297" and posted_year = 2016 sorted by posted_date descending
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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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-0297-0028 | 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 |
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id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
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posted_date TEXT,
posted_year INTEGER,
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comment_end_date TEXT,
last_modified TEXT,
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withdrawn INTEGER,
object_id TEXT
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CREATE INDEX idx_docs_year ON documents(posted_year);
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