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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameGORE-TEX(TM) SUTURE
Classification Namesuture, nonabsorbable, synthetic, polypropylene
Generic Namesuture, nonabsorbable, synthetic, polypropylene
Regulation Number878.5010
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP820083
Supplement NumberS025
Date Received07/23/1998
Decision Date08/27/1998
Product Code
GAW[ Registered Establishments with GAW ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) a change in suture needle material 2) a change in suture needle geometry, and 3) addition of a silicone coating to the suture needle.
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