PMA - Premarket Approval

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New Search Back to Search Results Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.   Trade Name RADIESSE 1.3CC AND 0.3CC Classification Name implant, dermal, for aesthetic use Generic Name injectable calcium hydroxylapatite implant for soft tissue augmentation for the treatment of facial lipoatrophy Applicant BIOFORM MEDICAL, INC. PMA Number P050037 Date Received 09/29/2005 Decision Date 12/22/2006 Product Code LMH [ Registered Establishments with LMH ] Docket Number 07M-0006 Notice Date 01/17/2007 Advisory Committee General & Plastic Surgery Expedited Review Granted? No Information About: Labeling, Approval Order, Summary of Safety and Effectiveness Approval Order Statement  Approval for radiesse. This device is indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Post-Approval Study Show Report Schedule and Study Progress Supplements: S001 S002 S003 S004 S005 S006  S008 S009 S011 S012 S013 S014  S015 S016 S017 S018 S019 S020