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
Dec 23, 2011
BIOMERIX ASSURE
Biomerix Corporation
General & Plastic Surgery
112d
Cleared
Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
Smith & Nephew, Inc.
General & Plastic Surgery
57d
Cleared
Aug 11, 2011
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
Sofradim Production
General & Plastic Surgery
156d
Cleared
Jun 14, 2011
HYDROFIX SURGICAL SHEET
Mimedx Group, Inc.
General & Plastic Surgery
495d
Cleared
May 13, 2011
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
Proxy Biomedical , Ltd.
General & Plastic Surgery
22d
Cleared
May 10, 2011
TORNIER BIOFIBER SCAFFOLD
Tornier, Inc.
General & Plastic Surgery
228d
Cleared
Apr 19, 2011
PARIETEX OPTIMIZED COMPOSTIE MESH
Sofradim Production
General & Plastic Surgery
26d
Cleared
Apr 19, 2011
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
Sofradim Production
General & Plastic Surgery
26d
Cleared
Apr 01, 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
9d
Cleared
Mar 23, 2011
VENTRIO ST HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
257d
Cleared
Mar 23, 2011
VENTRALEX ST HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
257d
Cleared
Mar 04, 2011
PARIETEX PROGRIP
Sofradim Production
General & Plastic Surgery
77d
Cleared
Feb 22, 2011
ALACER SURGICAL SCAFFOLD
Alacer Biomedical, Inc.
General & Plastic Surgery
90d
Cleared
Feb 15, 2011
ATRIUM CENTRILFX MESH
Atrium Medical Corporation
General & Plastic Surgery
32d
Cleared
Dec 22, 2010
RESTORELLE POLYPROPYLENE MESH
Coloplast A/S
General & Plastic Surgery
16d
Cleared
Dec 16, 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
83d
Cleared
Nov 05, 2010
PARIETEX PLUG AND PATCH
Sofradim Production
General & Plastic Surgery
156d
Cleared
Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
Smith & Nephew, Inc.
General & Plastic Surgery
182d
Cleared
Aug 16, 2010
ASCEND BLUE AC MESH
Caldera Medical, Inc.
General & Plastic Surgery
82d
Cleared
Jul 15, 2010
VENTRALIGHT ST MESH
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
14d
Cleared
Jun 25, 2010
SURGIMESH XD
Aspide Medical
General & Plastic Surgery
337d
Cleared
Jun 25, 2010
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
Cousin Biotech Sas
General & Plastic Surgery
259d
Cleared
May 13, 2010
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
Biomerix Corporation
General & Plastic Surgery
223d
Cleared
May 05, 2010
PARIE TENE PROGRIP MESH
Sofradim Production
General & Plastic Surgery
7d