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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.
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
5879 pacific center blvd.
san diego, CA 92121
PMA NumberP020012
Supplement NumberS007
Date Received02/07/2013
Decision Date02/19/2013
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.