|
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 | S024 |
Date Received | 03/29/2012 |
Decision Date | 04/16/2012 |
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 REVIEW TO INCREASE THE NUMBER OF SYRINGES DRIED IN THE DRYING OVENS AND HARMONIZE THE NUMBER OF SYRINGES DRIED PER DRYING CYCLE WITH THE NUMBER OF SYRINGES STERILIZED PER STERILIZATION CYCLE. |