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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 NumberS024
Date Received09/18/1996
Decision Date10/03/1996
Product Code
GAW[ Registered Establishments with GAW ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of two new indications: for use in the repair of dura mater and for use i the repair ofreplacement of chordae tendineae.
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