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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 SUTURE (DYED)
Generic NameSuture, surgical, absorbable, polydioxanone
Regulation Number878.4840
ApplicantETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville, NJ 08876
PMA NumberN18331
Supplement NumberS001
Date Received12/28/1981
Decision Date01/28/1982
Product Code NEW 
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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