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..
337
Total
337
Cleared
119d
Avg days
1979
Since
337 devices
Cleared
Feb 13, 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
W.L. Gore & Associates, Inc.
General & Plastic Surgery
73d
Cleared
Dec 14, 1994
GLYCAR TISSUE REPAIR PATCH
Glycar, Inc.
General & Plastic Surgery
176d
Cleared
Dec 08, 1994
TRELEX NATURAL(R) MESH
Meadox Medicals, Div. Boston Scientific Corp.
General & Plastic Surgery
45d
Cleared
Nov 09, 1994
ACM PTFE SURGICAL MESH
American Custom Medical, Inc.
General & Plastic Surgery
62d
Cleared
Sep 29, 1994
GORE-TEX SOFT TISSUE PATCH PLUS
W.L. Gore & Associates, Inc.
General & Plastic Surgery
856d
Cleared
Aug 23, 1994
FLARED PATCH
Flared Patch, Inc.
General & Plastic Surgery
159d
Cleared
Jul 08, 1994
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
Bio-Vascular, Inc.
General & Plastic Surgery
37d
Cleared
Jun 30, 1994
BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS
Bioplexus Corp.
General & Plastic Surgery
329d
Cleared
Jan 28, 1994
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
345d
Cleared
Jan 10, 1994
GIANTURCO-HELFRICH HERNIS MESH
Cook, Inc.
General & Plastic Surgery
266d
Cleared
Dec 16, 1993
ATRIUM POLYPROPYLENE MESH
Atrium Medical Corp.
General & Plastic Surgery
308d
Cleared
Nov 29, 1993
GORE-TEK(R) SOFT TISSUE PATCH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
335d
Cleared
Oct 29, 1993
GORE-TEX MICRO MESH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
234d
Cleared
Sep 09, 1993
GORE-TEX(TM) DUAL MESH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
252d
Cleared
Feb 12, 1993
AUTO SUTURE SURGICAL MESH DEPLOYER
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
122d
Cleared
Nov 23, 1992
TRELEX MESH
Meadox Medicals, Div. Boston Scientific Corp.
General & Plastic Surgery
62d
Cleared
Aug 24, 1992
BARD MARLEX MESH DART
C.R. Bard, Inc.
General & Plastic Surgery
68d
Cleared
May 29, 1992
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
171d
Cleared
Dec 04, 1991
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE
W.L. Gore & Associates, Inc.
General & Plastic Surgery
61d
Cleared
Dec 31, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
13d
Cleared
Jun 27, 1984
VENTRAL WALL DEFECT REDUCT SILO
American Heyer Schulte
General & Plastic Surgery
162d
Cleared
Jan 10, 1984
STERILIZATION OF GORE-TEX SOFT TISSU
W.L. Gore & Associates, Inc.
General & Plastic Surgery
76d
Cleared
Mar 26, 1982
GORE-TEX TISSUE REINFORCEMENT PATCH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
60d
Cleared
Mar 13, 1981
VICRYL
Ethicon, Inc.
General & Plastic Surgery
23d