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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.
 
DeviceBELLAFILL
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
SUNEVA MEDICAL, INC.
5879 pacific center blvd.
san diego, CA 92121
PMA NumberP020012
Supplement NumberS009
Date Received05/16/2014
Decision Date12/23/2014
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 14M-2376
Notice Date 12/30/2014
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00778531
NCT01559922
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the bellafill. This device is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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