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..
337
Total
337
Cleared
119d
Avg days
1979
Since
337 devices
Cleared
Jul 01, 1997
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
Technical Products, Inc.
General & Plastic Surgery
69d
Cleared
Feb 18, 1997
RAPISEAL PATCH
Fusion Medical Technologies, 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
Oct 11, 1996
KUGEL HERNIA PATCH
Douglas Bueschel
General & Plastic Surgery
59d
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
Sep 03, 1996
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
Tissue Technologies, Inc.
General & Plastic Surgery
69d
Cleared
Aug 09, 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
42d
Cleared
May 31, 1996
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
Fusion Medical Technologies, Inc.
General & Plastic Surgery
46d
Cleared
Apr 01, 1996
SOFT TISSUE AUGMENTATION TUBE
Tissue Technologies, Inc.
General & Plastic Surgery
59d
Cleared
Mar 15, 1996
PROLEX MESH
Advanced Surgical Innovations, Inc.
General & Plastic Surgery
59d
Cleared
Feb 14, 1996
GLYCAR STAPLE STRIPS
Glycar, Inc.
General & Plastic Surgery
127d
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
Sep 26, 1995
BARD VISILEX MESH 3 X 6
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
57d
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
Mar 02, 1995
HERNIA MESH INTRODUCTION SYSTEM
Gerard Medical, Inc.
General & Plastic Surgery
139d