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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.
 
DeviceNOVAFIL(TM)
Generic NameSuture, nonabsorbable, synthetic, polyester
Regulation Number878.5000
ApplicantDavis & Geck, Inc.
One Casper St.
Danbury, CT 06810
PMA NumberP840041
Supplement NumberS003
Date Received03/21/1988
Decision Date07/06/1990
Product Code GAS 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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