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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 AGENT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08540
PMA NumberP850010
Supplement NumberS072
Date Received08/19/2016
Decision Date09/15/2016
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Replacement of a portion of the water deionization (DI) system, located in the Collagen Manufacturing Center. Integra will replace a portion of the DI system with a new Evoqua IonRight GEN3 system. The change is being made to lower operating expenses, as well as reduce the frequency of service of the system by reducing the frequency at which the vessels are shipped off site for regeneration.
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