|
Device | RADIESSE, RADIESSE (+) [RADIESSE WITH LIDOCAINE] |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P050052 |
Supplement Number | S074 |
Date Received | 10/20/2015 |
Decision Date | 12/11/2015 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN PRODUCT LABELING ¿ UPDATE OF ADVERSE EFFECTS DESCRIPTIONS. |