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
Apr 04, 2001
IVS TUNNELLER
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
90d
Cleared
Feb 21, 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
W.L. Gore & Associates, Inc.
General & Plastic Surgery
28d
Cleared
Jan 24, 2001
SOFRADIM PARIETEX SURGICAL MESHES
Sofradim Production
General & Plastic Surgery
29d
Cleared
Jan 22, 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
Davol, Inc.
General & Plastic Surgery
90d
Cleared
Nov 29, 2000
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
American Medical Systems, Inc.
General & Plastic Surgery
90d
Cleared
Nov 22, 2000
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
86d
Cleared
Oct 11, 2000
COMPOSIX E/X MESH
C.R. Bard, Inc.
General & Plastic Surgery
44d
Cleared
Jul 24, 2000
ATRIUM LITE MESH
Atrium Medical Corp.
General & Plastic Surgery
13d
Cleared
May 23, 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
46d
Cleared
Mar 02, 2000
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
Genzyme Corp.
General & Plastic Surgery
71d
Cleared
Feb 17, 2000
PERMACOL
Tissue Science Laboratories, Plc
General & Plastic Surgery
202d
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
Nov 18, 1999
STAR TEMPORARY WOUND COVER
Osteogenics, Inc.
General & Plastic Surgery
398d
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
Jun 22, 1999
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
41d
Cleared
Jun 17, 1999
3D ANATOMICAL MESH
Santerra Medical Technology, Inc.
General & Plastic Surgery
90d
Cleared
Feb 23, 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
90d
Cleared
Jan 20, 1999
PARIETEX
Cogent
General & Plastic Surgery
184d
Cleared
Jan 07, 1999
FLUOROTEX SURGICAL MESH
Bridger Biomed, Inc.
General & Plastic Surgery
45d
Cleared
Nov 06, 1998
MESH, SURGICAL, POLYMERIC
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
105d
Cleared
Sep 22, 1998
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
Tissue Technologies, Inc.
General & Plastic Surgery
68d
Cleared
Aug 05, 1998
SHELHIGH NO-REACT PNEUMOPLEDGETS
Shelhigh, Inc.
General & Plastic Surgery
79d