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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received05/07/1990
Decision Date03/01/1996
Product Code
MGR[ Registered Establishments with MGR ]
Docket Number 96M-0203
Notice Date 07/18/1996
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the integra artifical skin.
Supplements: S001 S002 S003 S005 S006 S007 
S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 
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