Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
FDA product code OTO · 20 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.3300
- Review panel
- OB
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2001-04-09 – 2017-12-15
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
OTO
2017-12-15
OTO
2013-08-02
RESTORELLE M, RESTORELLE XL
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OTO
2013-04-25
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
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OTO
2013-03-05
RESTORELLE Y CONTOUR
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OTO
2013-02-21
VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
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OTO
2012-12-18
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
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2012-12-18
UPSYLON Y MESH
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2012-11-19
RESTORELLE L
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2012-10-16
AMS LARGE PORE POLYPROPHLENE MESH
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2012-06-11
ARTISYN Y-SHAPED MESH
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2012-05-17
RESTORELLE POLYPROPYLENE Y MESH
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2012-05-10
VERTESSA
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2011-04-01
ALYTE Y-MESH GRAFT
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2009-11-10
BARD SACROCOLPOPEXY GRAFT
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2006-02-06
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
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2005-08-03
AMS PELVIC FLOOR REPAIR SYSTEM
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OTO
2005-06-17
POLYFORM SYNTHETIC MESH
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OTO
2004-11-17
MINIMESH POLYPROPYLENE MESH
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OTO
2002-01-08
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
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OTO
2001-04-09
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
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