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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, 1.3 CC AND 0.3 CC
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable calcium hydroxylapatite implant for soft tissue augmentation for the treatment of facial lipoatrophy
ApplicantBIOFORM MEDICAL, INC.
PMA NumberP050037
Supplement NumberS003
Date Received05/18/2007
Decision Date04/21/2008
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified product that contains phosphate buffer solution, has a lower extrusion force than the original radiesse product, and is manufactured using a one-step process.
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