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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
Generic NameSuture, surgical, absorbable, polydioxanone
Regulation Number878.4840
ApplicantETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville, NJ 08876
PMA NumberN18331
Supplement NumberS025
Date Received05/24/1995
Decision Date11/02/1995
Product Code NEW 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR USE OF THE PDS II SUTURE IN HTE PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
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