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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 facial lipoatrophy
ApplicantBIOFORM MEDICAL, INC.
PMA NumberP050037
Supplement NumberS017
Date Received12/09/2008
Decision Date02/03/2009
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1. Changing the fill volume from a maximum deliverable fill volume of 1. 3 cc to a maximum deliverable fill volume of 1. 5 cc. 2. Changing the syringe barrel handle from a molded straight handle to a molded handle with an ergonomic curved handle. 3. Modification to the instruction for use to include the 1. 5 cc fill volume in the device description section of the instructions for use. 4. Creation of package labeling specific to the 1. 5 cc fill volume, identical to the package labeling for the 0. 3 cc and 1. 3 cc fill volume products with the exception of the identified fill volume and part number.
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