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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namesuture, nonabsorbable, synthetic, polypropylene
Generic Namesuture, nonabsorbable, synthetic, polypropylene
Regulation Number878.5010
PMA NumberP820083
Supplement NumberS023
Date Received09/16/1996
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 
Addition of two new indications: for use in the repair of dura mater and for use in the repair of replacement of chordae tendineae.