|
Device | BELOTERO BALANCE 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 | S011 |
Date Received | 08/06/2014 |
Decision Date | 09/09/2014 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement SAMPLING CHANGES DURING PRODUCT MANUFACTURE AND DURING FINAL RELEASE TESTING FOR THE BELOTERO BALANCE PRODUCT. |