|
Device | JUVEDERM HYALURONATE |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S022 |
Date Received | 01/25/2012 |
Decision Date | 02/24/2012 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF A NEW PRECAUTION STATEMENT: FAILURE TO COMPLY WITH THESE INSTRUCTIONS COULD RESULT IN NEEDLE DISENGAGEMENT AND/OR PRODUCT LEAKAGE AT TE LUER-LOCK NEEDLE HUB CONNECTION. |