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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRADIESSE INJECTABLE IMPLANT
Generic NameImplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
4133 COURTNEY ROAD
SUITE 10
FRANKSVILLE, WI 53126
PMA NumberP050037
Supplement NumberS017
Date Received12/09/2008
Decision Date02/03/2009
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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 DEVICEDESCRIPTION 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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