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
Sep 18, 2007
SPORTMESH OR ARTELON TISSUE REINFORCEMENT
Artimplant AB
General & Plastic Surgery
71d
Cleared
Aug 31, 2007
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
Implantech Associates, Inc.
General & Plastic Surgery
94d
Cleared
Aug 22, 2007
4DDOME
Cousin Biotech
General & Plastic Surgery
142d
Cleared
Aug 16, 2007
REBOUND HRD
Minnesota Medical Development, Inc.
General & Plastic Surgery
248d
Cleared
Aug 01, 2007
PELVIMESH / HERMESH 7
Marketing Solutions, Inc.
General & Plastic Surgery
148d
Cleared
Jul 17, 2007
XTAC
Osteogenics, Inc.
General & Plastic Surgery
375d
Cleared
Jul 10, 2007
FACIAL RECONSTRUCTIVE MESH (FRM)
Evera Medical, Inc.
General & Plastic Surgery
267d
Cleared
Jul 10, 2007
PARIETEX POLYESTER MESH WITH INTRODUCER
Sofradim Production
General & Plastic Surgery
26d
Cleared
Jul 02, 2007
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
Prosurg, Inc.
General & Plastic Surgery
96d
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 27, 2007
UNIVERSAL SURGICAL MESH, MODEL 100
Generic Medical Device, Inc.
General & Plastic Surgery
114d
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
Mar 07, 2007
SURGI-WRAP MAST TENDON SHEET
Mast Biosurgery USA, Inc.
General & Plastic Surgery
90d
Cleared
Feb 01, 2007
SURGIMESH WN
Aspide Medical
General & Plastic Surgery
253d
Cleared
Jan 17, 2007
SEPRAMESH, MODEL 5959-1214
Genzyme Corporation
General & Plastic Surgery
30d
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
Oct 23, 2006
BARD COMPOSITE L/P MESH
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
124d
Cleared
Oct 13, 2006
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
Cook Biotech, Inc.
General & Plastic Surgery
32d
Cleared
Sep 21, 2006
SURGI-WRAP MAST BIORESORBABLE SHEET
Mast Biosurgery USA, Inc.
General & Plastic Surgery
114d
Cleared
Sep 11, 2006
ENDOFAST RELIANT SYSTEM
Endogun Medical Systems
General & Plastic Surgery
214d