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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameNOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE
Classification Namesuture, nonabsorbable, synthetic, polyester
Generic Namesuture, nonabsorbable, synthetic, polyester
Regulation Number878.5000
ApplicantDAVIS & GECK, INC.
PMA NumberP840041
Supplement NumberS006
Date Received12/19/1995
Decision Date01/11/1996
Product Code
GAS[ Registered Establishments with GAS ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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