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
Oct 07, 2008
BARD 3DMAX MESH
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
181d
Cleared
Sep 29, 2008
VENTRIO HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
98d
Cleared
Sep 15, 2008
SUPRAMESH EXTRA
S. Jackson, Inc.
General & Plastic Surgery
230d
Cleared
Sep 05, 2008
TBD ETHICON MESH
Ethicon, Inc.
General & Plastic Surgery
30d
Cleared
Aug 18, 2008
SURGIMESH XB
Aspide Medical
General & Plastic Surgery
301d
Cleared
Aug 18, 2008
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
Feg Textiltechnik Forschungs-Und Entwicklungsgesel
General & Plastic Surgery
242d
Cleared
Aug 13, 2008
PARIETEX COMPOSITE MONO PM MESH
Sofradim Production
General & Plastic Surgery
114d
Cleared
Jul 24, 2008
SURGICRAFT SURGICAL MESH SYSTEM
Surgicraft , Ltd.
General & Plastic Surgery
336d
Cleared
Jun 26, 2008
CABS'AIR
Cousin Biotech Sas
General & Plastic Surgery
251d
Cleared
Jun 19, 2008
RELIMESH
Herniamesh S.R.L.
General & Plastic Surgery
38d
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 21, 2008
MODIFICATION TO ENDOFAST RELIANT SYSTEM
Endogun Medical Systems
General & Plastic Surgery
27d
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
Apr 03, 2008
LTM-T SURGICAL MESH
Lifecell Corp.
General & Plastic Surgery
52d
Cleared
Mar 13, 2008
PREVADH MESH
Sofradim Production
General & Plastic Surgery
113d
Cleared
Mar 13, 2008
MODIFICATION TO REBOUND HRD
Minnesota Medical Development, Inc.
General & Plastic Surgery
29d
Cleared
Mar 05, 2008
IVS TUNNELLER DEVICES
Covidien UK Manufacturing, Ltd.
General & Plastic Surgery
117d
Cleared
Feb 25, 2008
BIOMERIX SURGICAL MESH, MODEL: RCR-01
Biomerix Corporation
General & Plastic Surgery
326d
Cleared
Jan 16, 2008
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
Tyrx Pharma, Inc.
General & Plastic Surgery
463d
Cleared
Jan 16, 2008
ORTHO-WRAP BIORESORBABLE SHEET
Mast Biosurgery
General & Plastic Surgery
163d
Cleared
Dec 31, 2007
KENSEY NASH MACROPORE SHIELD
Kensey Nash Corp.
General & Plastic Surgery
194d
Cleared
Nov 29, 2007
TEPHAFLEX SURGICAL FILM
Tepha, Inc.
General & Plastic Surgery
83d