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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINTEGRA/DERMAL REGENERATION TEMPLATE
Classification Namedressing, wound and burn, interactive
Generic Nameartificial skin burn wound covering
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP900033
Supplement NumberS006
Date Received06/19/2001
Decision Date08/10/2001
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update of the device labeling to incorporate the results of the postapproval study.
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