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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(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE
Generic NameSuture, nonabsorbable, synthetic, polyester
Regulation Number878.5000
ApplicantDavis & Geck, Inc.
One Casper St.
Danbury, CT 06810
PMA NumberP840041
Supplement NumberS006
Date Received12/19/1995
Decision Date01/11/1996
Product Code GAS 
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
Approval Order Statement  
APPROVAL FOR A REVISION OF THE EXISTING PACKAGE INSERTS, UNDER THE PROVISIONS OF 814.39(D)(1), SPECIAL PMA SUPPLEMENT-CHANGES BEING EFFECTED
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