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 nasolabial folds Applicant BIOFORM MEDICAL, INC. PMA Number P050052 Date Received 12/22/2005 Decision Date 12/22/2006 Product Code LMH [ Registered Establishments with LMH ] Docket Number 07M-0007 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 the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Post-Approval Study Show Report Schedule and Study Progress Supplements: S002 S003 S004 S005 S006 S007  S009 S010 S012 S013 S014 S015  S016 S017 S018 S019 S020 S021  S022