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 Sofradim Production, W.L. Gore & Associates, Inc. and C.R. Bard, Inc..
336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
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 14, 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
Kci USA, Inc.
General & Plastic Surgery
78d
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
Oct 07, 2008
BARD 3DMAX MESH
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
181d
Cleared
Sep 29, 2008
VENTRIO HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
98d
Cleared
Sep 15, 2008
SUPRAMESH EXTRA
S. Jackson, Inc.
General & Plastic Surgery
230d
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
Cleared
May 30, 2008
GORE INFINIT MESH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
45d
Cleared
May 28, 2008
PARIETEX PROGRIP MESH
Sofradim Production
General & Plastic Surgery
44d
Cleared
Apr 16, 2008
C-QUR LITE MESH V-PATCH
Atrium Medical Corp.
General & Plastic Surgery
36d
Cleared
Apr 16, 2008
C-QUR EDGE MESH V-PATCH
Atrium Medical Corp.
General & Plastic Surgery
36d
Cleared
Mar 13, 2008
PREVADH MESH
Sofradim Production
General & Plastic Surgery
113d
Cleared
Dec 31, 2007
KENSEY NASH MACROPORE SHIELD
Kensey Nash Corp.
General & Plastic Surgery
194d
Cleared
Nov 29, 2007
TEPHAFLEX SURGICAL FILM
Tepha, Inc.
General & Plastic Surgery
83d
Cleared
Aug 31, 2007
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
Implantech Associates, Inc.
General & Plastic Surgery
94d
Cleared
Jul 10, 2007
PARIETEX POLYESTER MESH WITH INTRODUCER
Sofradim Production
General & Plastic Surgery
26d
Cleared
Jul 02, 2007
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
Prosurg, Inc.
General & Plastic Surgery
96d
Cleared
Jun 05, 2007
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
Ethicon, Inc.
General & Plastic Surgery
32d
Cleared
May 09, 2007
TOPAS SYSTEM
American Medical Systems, Inc.
General & Plastic Surgery
30d