|
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 | S033 |
Date Received | 12/04/2013 |
Decision Date | 04/17/2014 |
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 | Yes |
Approval Order Statement APPROVAL FOR A CHANGE TO THE QUALITY CONTROL TESTING METHOD USED TO CONFIRM THE CONCENTRATION OF LIDOCAINE AND LIDOCAINE DEGREDANTS IN JUVÉDERM HYALURONATE GEL IMPLANTS. |