|
Device | BELOTERO BALANCE |
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 | S019 |
Date Received | 12/01/2015 |
Decision Date | 03/29/2017 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 review track for 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the addition of temperature monitoring devices to trans-Atlantic shipments and changes to the incoming inspection procedure. |