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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
Generic Nameinjectable calcium hydroxylapatite implant for soft tissue augmentation for the treatment of nasolabial folds
ApplicantBIOFORM MEDICAL, INC.
PMA NumberP050052
Supplement NumberS019
Date Received01/14/2009
Decision Date07/13/2009
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the instructions for use to provide detailed instructions for mixing radiesse with 2% lidocaine hcl (resulting in a final concentration of 0. 3% lidocaine) prior to injection for the indicated use of subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The mixing of radiesse and lidocaine is to be accomplished using a mixing kit that will be made available separate from the radiesse device.
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