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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 AGENT MICROFIBRILLAR
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP810006
Supplement NumberS046
Date Received08/14/2013
Decision Date04/08/2014
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 THE FOLLOWING PROPOSED CHANGES: 1) CLEANING VALIDATION FOR THE MICROFIBRILLAR GRINDING PROCESS EQUIPMENT; 2) ESTABLISHMENT OF DIRTY HOLD TIME;3) TOTAL ORGANIC CARBON (TOC) RECOVERY STUDY FOR SWAB AND RINSE ON STAINLESS STEEL SURFACES; AND4) TOC RECOVERY STUDY FOR SWAB AND RINSE ON TEFLON SURFACES.
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