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..
336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
Cleared
May 30, 2008
GORE INFINIT MESH
W.L. Gore & Associates, Inc.
General & Plastic Surgery
45d
Cleared
May 28, 2008
PARIETEX PROGRIP MESH
Sofradim Production
General & Plastic Surgery
44d
Cleared
Apr 16, 2008
C-QUR LITE MESH V-PATCH
Atrium Medical Corp.
General & Plastic Surgery
36d
Cleared
Apr 16, 2008
C-QUR EDGE MESH V-PATCH
Atrium Medical Corp.
General & Plastic Surgery
36d
Cleared
Mar 13, 2008
PREVADH MESH
Sofradim Production
General & Plastic Surgery
113d
Cleared
Aug 31, 2007
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
Implantech Associates, Inc.
General & Plastic Surgery
94d
Cleared
Jul 10, 2007
PARIETEX POLYESTER MESH WITH INTRODUCER
Sofradim Production
General & Plastic Surgery
26d
Cleared
Jun 05, 2007
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
Ethicon, Inc.
General & Plastic Surgery
32d
Cleared
May 09, 2007
TOPAS SYSTEM
American Medical Systems, Inc.
General & Plastic Surgery
30d
Cleared
Apr 17, 2007
ULTRAPRO PLUG
Ethicon, Inc.
General & Plastic Surgery
83d
Cleared
Apr 02, 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
W.L. Gore & Associates, Inc.
General & Plastic Surgery
25d
Cleared
Mar 08, 2007
ATRIUM PROLITE ULTRA S MESH
Atrium Medical Corp.
General & Plastic Surgery
45d
Cleared
Dec 11, 2006
PROCEED VENTRAL PATCH
Ethicon, Inc.
General & Plastic Surgery
192d
Cleared
Nov 28, 2006
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
15d
Cleared
Jul 19, 2006
OPTILENE MESH
Aesculap, Inc.
General & Plastic Surgery
33d
Cleared
Jul 17, 2006
SURGICAL MESH SYSTEM
Nuvasive, Inc.
General & Plastic Surgery
242d
Cleared
May 25, 2006
PROCEED SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
69d
Cleared
Mar 31, 2006
ATRIUM MEDICAL CORPORATION C-QUR MESH
Atrium Medical Corp.
General & Plastic Surgery
416d
Cleared
Jan 18, 2006
OPTILENE MESH LP
Aesculap, Inc.
General & Plastic Surgery
65d
Cleared
Dec 07, 2005
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
21d
Cleared
Oct 20, 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
C.R. Bard, Inc.
General & Plastic Surgery
73d
Cleared
Sep 29, 2005
VICRYL * MESH BAG
Ethicon, Inc.
General & Plastic Surgery
97d
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