• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
Trade NameGORE-TEX(R) EXPANDED PTFE SUTURE
Classification Namesuture, nonabsorbable, synthetic, polypropylene
Generic Namesuture, nonabsorbable, synthetic, polypropylene
Regulation Number878.5010
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP820083
Supplement NumberS009
Date Received11/18/1988
Decision Date03/09/1989
Product Code
GAW[ Registered Establishments with GAW ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
-
-