|
Device | RADIESSE INJECTABLE IMPLANT |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P050037 |
Supplement Number | S024 |
Date Received | 07/02/2010 |
Decision Date | 10/31/2011 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A NEW PRODUCT FILL VOLUME (I.E., 3.0CC). |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |