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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameRADIESSE INJECTABLE IMPLANT
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable calcium hydroxylapatite implant for soft tissue augmentation for the treatment of nasolabial folds
ApplicantMERZ NORTH AMERICA, INC
PMA NumberP050052
Date Received12/22/2005
Decision Date12/22/2006
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
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
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.
Approval Order Approval Order
Post-Approval StudyShow 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 S024 S025 S026 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S050 
S051 
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