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
Feb 14, 2000
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
W.L. Gore & Associates, Inc.
General & Plastic Surgery
25d
Cleared
Jan 27, 2000
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
Atrium Medical Corp.
General & Plastic Surgery
142d
Cleared
Jul 29, 1999
GORE-TEX DUALMESH BIOMATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
30d
Cleared
Jul 12, 1999
PARIETENE POLYPROPYLENE MESH
Sofradim Production
General & Plastic Surgery
81d
Cleared
Feb 23, 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
90d
Cleared
Nov 06, 1998
MESH, SURGICAL, POLYMERIC
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
105d
Cleared
Apr 30, 1998
MENTOR SUSPEND SLING
Mentor Corp.
General & Plastic Surgery
80d
Cleared
Apr 15, 1998
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
W.L. Gore & Associates, Inc.
General & Plastic Surgery
28d
Cleared
Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
76d
Cleared
Feb 06, 1997
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
W.L. Gore & Associates, Inc.
General & Plastic Surgery
51d
Cleared
Jan 27, 1997
S.A.M. FACIAL IMPLANT W/INTRODUCER
W.L. Gore & Associates, Inc.
General & Plastic Surgery
61d
Cleared
Nov 15, 1996
SURGICAL FABRICS
Boston Scientific Corp
General & Plastic Surgery
88d
Cleared
Oct 25, 1996
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
W.L. Gore & Associates, Inc.
General & Plastic Surgery
45d
Cleared
Sep 16, 1996
POLYPROPYLENE MESH (VARIOUS SIZES)
Davis & Geck, Inc.
General & Plastic Surgery
47d
Cleared
Sep 03, 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
W.L. Gore & Associates, Inc.
General & Plastic Surgery
74d
Cleared
Aug 09, 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
42d
Cleared
Jan 24, 1996
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
W.L. Gore & Associates, Inc.
General & Plastic Surgery
54d
Cleared
Nov 14, 1995
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
W.L. Gore & Associates, Inc.
General & Plastic Surgery
144d
Cleared
Oct 07, 1995
GORE-TEX MYCROMESH BIOMATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
179d
Cleared
Oct 07, 1995
GORE-TEX DUALMESH BIOMATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
179d
Cleared
Oct 07, 1995
GORE-TEX SOFT TISSUE PATCH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
178d
Cleared
Apr 24, 1995
GORE-TEX DUALMESH PLUS BIOMATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
131d
Cleared
Apr 24, 1995
GORE-TEX MYCROMESH PLUS BIOMATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
131d
Cleared
Feb 13, 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
W.L. Gore & Associates, Inc.
General & Plastic Surgery
73d