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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.
 
DeviceCollastat™ Absorbable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP810006
Supplement NumberS108
Date Received06/24/2024
Decision Date07/24/2024
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementation of the Vaisala viewLinc Countinous Monitoring system for temperature and relative humidity monitoring of manufacturing cleanrooms and laboratory rooms at the Integra NeuroSciences Anasco, PR facility
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