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 Sofradim Production, W.L. Gore & Associates, Inc. and C.R. Bard, Inc..
337
Total
337
Cleared
119d
Avg days
1979
Since
337 devices
Cleared
May 16, 2005
TISSUE FIXATION SYSTEM
Tfs Manufacturing Pty, Ltd.
General & Plastic Surgery
87d
Cleared
Feb 18, 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
Sofradim Production
General & Plastic Surgery
22d
Cleared
Dec 22, 2004
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
47d
Cleared
Dec 22, 2004
GORE POLYPROPYLENE HERNIA MESH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
44d
Cleared
Dec 17, 2004
PERMACOL SURGICAL IMPLANT
Tissue Science Laboratories, Plc
General & Plastic Surgery
9d
Cleared
Nov 08, 2004
VIVOSORB SHEET, MODEL FS01
Polyganics B.V.,
General & Plastic Surgery
27d
Cleared
Sep 10, 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
C.R. Bard, Inc.
General & Plastic Surgery
44d
Cleared
Apr 29, 2004
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
Sofradim Production
General & Plastic Surgery
10d
Cleared
Apr 01, 2004
ULTRAPRO MESH
Ethicon, Inc.
General & Plastic Surgery
167d
Cleared
Mar 01, 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
C.R. Bard, Inc.
General & Plastic Surgery
83d
Cleared
Jan 15, 2004
UGYTEX MESH
Sofradim Production
General & Plastic Surgery
85d
Cleared
Dec 19, 2003
SHELHIGH NO-REACT BIOCUFF
Shelhigh, Inc.
General & Plastic Surgery
93d
Cleared
Nov 28, 2003
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
77d
Cleared
Oct 02, 2003
IMMIX PLASTIFILM
Osteobiologics, Inc.
General & Plastic Surgery
34d
Cleared
Sep 29, 2003
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
Gfe Medizintechnik GmbH
General & Plastic Surgery
165d
Cleared
Sep 22, 2003
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
Macropore Biosurgery, Inc.
General & Plastic Surgery
89d
Cleared
Sep 17, 2003
PROCEED TRILAMINATE SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
86d
Cleared
Aug 15, 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
30d
Cleared
Jun 27, 2003
ORTHOMEND
Tei Biosciences, Inc.
General & Plastic Surgery
73d
Cleared
May 19, 2003
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
Prosurg, Inc.
General & Plastic Surgery
80d
Cleared
Mar 14, 2003
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
Osteobiologics, Inc.
General & Plastic Surgery
84d
Cleared
Feb 26, 2003
V.A.C. ABDOMINAL DRESSING
Kinetic Concepts, Inc.
General & Plastic Surgery
252d
Cleared
Feb 20, 2003
SMALL BARD VENTRALEX PATCH
C.R. Bard, Inc.
General & Plastic Surgery
78d
Cleared
Dec 12, 2002
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
Center For Biomaterials and Advanced Technologies
General & Plastic Surgery
69d