|
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 | S009 |
Date Received | 06/30/2008 |
Decision Date | 07/30/2008 |
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 ELIMINATING THE USE OF BIOLOGICAL INDICATORS IN THE SECOND STERILIZATION CYCLE IN A SECOND AUTOCLAVE USED TO STERILIZE THE RADIESSE INJECTABLE IMPLANT. |