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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
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP810006
Supplement NumberS075
Date Received01/30/2017
Decision Date03/01/2017
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  
Acknowledge Integras revisions to Integras LifeSciences Standard Operating Procedure (SOP) QTM-10-007 - Design Output Variable, and Manufacturing Control Quality Assurance Levels, to align with the recently updated ISO 14971:2012 Medical devices - Application of risk management to medical devices.
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