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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 NumberS010
Date Received06/30/2008
Decision Date07/30/2008
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Eliminating the use of biological indicators in the second sterilization cycle in a second autoclave used to sterilize the radiesse injectable implant.
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