FDA Product Code FTL: Mesh, Surgical, Polymeric
Surgical mesh has transformed the repair of abdominal wall defects. FDA product code FTL covers polymeric surgical mesh used for tissue reinforcement and repair.
These woven or knitted synthetic materials — typically polypropylene or polyester — provide structural support to weakened or deficient tissue in hernia repair, pelvic floor reconstruction, and other procedures where native tissue alone is insufficient for durable closure.
FTL devices are Class II medical devices, regulated under 21 CFR 878.3300 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include W.L. Gore & Associates, Inc., Sofradim Production and C.R. Bard, Inc..
336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
Cleared
Apr 19, 2011
PARIETEX OPTIMIZED COMPOSTIE MESH
Sofradim Production
General & Plastic Surgery
26d
Cleared
Apr 19, 2011
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
Sofradim Production
General & Plastic Surgery
26d
Cleared
Apr 01, 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
9d
Cleared
Mar 23, 2011
VENTRIO ST HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
257d
Cleared
Mar 23, 2011
VENTRALEX ST HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
257d
Cleared
Mar 04, 2011
PARIETEX PROGRIP
Sofradim Production
General & Plastic Surgery
77d
Cleared
Dec 22, 2010
RESTORELLE POLYPROPYLENE MESH
Coloplast A/S
General & Plastic Surgery
16d
Cleared
Dec 16, 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
83d
Cleared
Nov 05, 2010
PARIETEX PLUG AND PATCH
Sofradim Production
General & Plastic Surgery
156d
Cleared
Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
Smith & Nephew, Inc.
General & Plastic Surgery
182d
Cleared
May 05, 2010
PARIE TENE PROGRIP MESH
Sofradim Production
General & Plastic Surgery
7d
Cleared
Apr 22, 2010
TORNIER SURGICAL MESH
Tornier, Inc.
General & Plastic Surgery
133d
Cleared
Apr 21, 2010
VENTRIO HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
85d
Cleared
Jan 26, 2010
ATRIUM C-QUR OVT MESH
Atrium Medical Corp.
General & Plastic Surgery
14d
Cleared
Aug 03, 2009
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
C.R. Bard, Inc.
General & Plastic Surgery
55d
Cleared
Jun 04, 2009
C-QUR V -PATCH MESH
Atrium Medical Corp.
General & Plastic Surgery
64d
Cleared
Jun 02, 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
American Medical Systems, Inc.
General & Plastic Surgery
61d
Cleared
May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
Sofradim Production
General & Plastic Surgery
37d
Cleared
Mar 27, 2009
GORE BIO-A FISTULA PLUG
W.L. Gore & Associates, Inc.
General & Plastic Surgery
142d
Cleared
Jan 15, 2009
NUVASIVE SURGICAL MESH SYSTEM
Nuvasive, Inc.
General & Plastic Surgery
244d
Cleared
Jan 14, 2009
ATRIUM PROLITE S MESH
Atrium Medical Corp.
General & Plastic Surgery
117d
Cleared
Sep 29, 2008
VENTRIO HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
98d
Cleared
Sep 05, 2008
TBD ETHICON MESH
Ethicon, Inc.
General & Plastic Surgery
30d
Cleared
Aug 13, 2008
PARIETEX COMPOSITE MONO PM MESH
Sofradim Production
General & Plastic Surgery
114d