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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 NameDevice, dermal replacement
ApplicantIntegra LifeSciences Corp.
105 MORGAN LN.
PLAINSBORO, NJ 08536
PMA NumberP900033
Supplement NumberS006
Date Received06/19/2001
Decision Date08/10/2001
Product Codes MDD MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN UPDATE OF THE DEVICE LABELING TO INCORPORATE THE RESULTS OF THE POSTAPPROVAL STUDY.
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