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
May 20, 1998
SIS HERNIA REPAIR DEVICE
Sentron Medical, Inc.
General & Plastic Surgery
168d
Cleared
May 11, 1998
HERNIAMESH SURGICAL MESHES
Herniamesh
General & Plastic Surgery
207d
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
Nov 24, 1997
SOFTFORM FACIAL IMPLANT
Tissue Technologies, Inc.
General & Plastic Surgery
73d
Cleared
Nov 04, 1997
VENTRAL WALL DEFECT REDUCTION SILO
Specialty Surgical Products, Inc.
General & Plastic Surgery
78d
Cleared
Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
76d
Cleared
Aug 06, 1997
BARD COMPOSITE PROSTHESIS
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
86d
Cleared
Aug 01, 1997
GRAFT PATCH
Organogenesis, Inc.
General & Plastic Surgery
169d
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