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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.
 
DeviceHELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Plainsboro, NJ 08540
PMA NumberP850010
Supplement NumberS002
Date Received06/19/1986
Decision Date08/18/1986
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type 30-Day Supplement
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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