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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/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Plainsboro, NJ 08540
PMA NumberP850010
Supplement NumberS016
Date Received06/08/2001
Decision Date06/29/2001
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
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 THE REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE INDICATIONS STATEMENT.
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