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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 NumberS010
Date Received06/17/1982
Decision Date07/16/1982
Product Code GAT 
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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