|
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 | S083 |
Date Received | 10/19/2017 |
Decision Date | 11/30/2017 |
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 Remove impressions (disruptions) in the waffle pattern of the seal for foil autoclavable pouches as a critical defect. |