|
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 | S023 |
Date Received | 02/21/2012 |
Decision Date | 03/20/2012 |
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 APPROVAL OF TWO CHANGES: 1) ADDITION OF A WAITING PERIOD WHILE THE GEL IS SITTING IN THE MOBILE TANK AND; 2) AN ENVIRONMENTAL CHANGE IN THE SECONDARY PACKAGING ROOM OF THE PRINGY I MANUFACTURING FACILITY. |