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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NamePDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
Classification Namesuture, absorbable, synthetic, polyglycolic acid
Generic Namesuture, absorbable, synthetic, polyglycolic acid
Regulation Number878.4493
ApplicantETHICON, INC.
PMA NumberN18331
Supplement NumberS025
Date Received05/24/1995
Decision Date11/02/1995
Product Code
GAM[ Registered Establishments with GAM ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the pds ii suture in hte panalok absorbable suture anchor system.
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