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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.
 
DeviceINTEGRA DERMAL REGENERATION TEMPLATE
Generic NameDressing, wound and burn, interactive
ApplicantIntegra LifeSciences Corp.
105 MORGAN LN.
PLAINSBORO, NJ 08536
PMA NumberP900033
Supplement NumberS060
Date Received01/30/2017
Decision Date03/01/2017
Product Code MGR 
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  
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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