|
Device | BELOTERO BALENCE DERMAL FILLER |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P090016 |
Supplement Number | S002 |
Date Received | 07/02/2012 |
Decision Date | 08/10/2012 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE BELOTERO BALANCE INSTRUCTIONS FOR USE TO INCLUDE 27 GAUGE NEEDLES AS AN OPTION FOR INJECTION. |