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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 Namedevice, dermal replacement
Generic Namedevice, dermal replacement
ApplicantIntegra LifeSciences Corp.
PMA NumberP900033
Supplement NumberS032
Date Received11/01/2013
Decision Date03/18/2014
Product Code
MDD[ Registered Establishments with MDD ]
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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