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
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
Cleared
Nov 27, 1979
USHER'S MARLEX TUBULAR MESH
Davol, Inc.
General & Plastic Surgery
14d