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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 NumberS047
Date Received11/06/2013
Decision Date10/31/2014
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN CLEANING VALIDATION PROCESS FOR MANUFACTURING EQUIPMENT.
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