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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.
 
DeviceDEXON
Generic NameSuture, absorbable, synthetic, polyglycolic acid
Regulation Number878.4493
ApplicantDavis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury, CT 06810
PMA NumberN16881
Supplement NumberS009
Date Received10/28/1986
Decision Date05/19/1987
Product Code GAM 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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