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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 ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Classification Namedressing, wound and burn, interactive
Generic Nameartificial skin burn wound covering
ApplicantINTEGRA LIFESCIENCES
PMA NumberP900033
Supplement NumberS032
Date Received11/04/2013
Decision Date03/18/2014
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for adding increased system capacity for water purification of the current reverse osmosis/electro-deionization water purification system (roedi).
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