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
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
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