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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 NumberS012
Date Received08/23/2004
Decision Date09/17/2004
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Extension of the allowed holding time for one of the manufacturing processes.
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