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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 NameRADIESSE INJECTABLE IMPLANT
Classification Nameimplant, dermal, for aesthetic use in the hands
Generic Nameinjectable calcium hydroxylapatite implant for soft tissue augmentation for the treatment of nasolabial folds
ApplicantMERZ NORTH AMERICA, INC
PMA NumberP050052
Supplement NumberS049
Date Received12/02/2013
Decision Date06/04/2015
Product Code
PKY[ Registered Establishments with PKY ]
Advisory Committee General & Plastic Surgery
Clinical Trials NCT01004107
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the radiesse® injectable implant. The device is indicated for hand augmentation to correct volume loss in the dorsum of the hands.
Approval Order Approval Order
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