|
Device | Juvederm® Hyaluronate Gel Implants |
Generic Name | implant, dermal, for aesthetic use |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P050047 |
Supplement Number | S056 |
Date Received | 02/09/2017 |
Decision Date | 05/12/2017 |
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 for a change in the cleaning procedure for some equipment used in the manufacturing of injectable gel products |