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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.
 
DeviceSURGILENE
Generic NameSuture, nonabsorbable, synthetic, polyethylene
Regulation Number878.5000
ApplicantDavis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury, CT 06810
PMA NumberN17825
Supplement NumberS016
Date Received02/02/1988
Decision Date03/01/1988
Product Code GAT 
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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