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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameGORE-TEX(R) SUTURE
Classification Namesuture, nonabsorbable, synthetic, polypropylene
Generic Namesuture, nonabsorbable, synthetic, polypropylene
Regulation Number878.5010
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP820083
Supplement NumberS020
Date Received01/30/1995
Decision Date06/05/1995
Product Code
GAW[ Registered Establishments with GAW ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
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