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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.
 
DeviceVICRYL (POLYGLACTIN 910) SUTURE
Generic NameSuture, absorbable, synthetic
Regulation Number878.4830
ApplicantETHICON, Inc.
Rte. 22 W.
Somerville, NJ 08876
PMA NumberN17472
Supplement NumberS043
Date Received09/01/1987
Decision Date10/05/1987
Product Code GAN 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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