Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S077 |
Date Received | 06/19/2020 |
Decision Date | 07/17/2020 |
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 revisions to the clinician labeling of Juvéderm® Ultra, Juvéderm® Ultra XC, Juvéderm® Ultra Plus, Juvéderm® Ultra Plus XC, Juvéderm® Vollure XC, and Juvéderm® Volbella XC to include updated safety information based on post marketing surveillance data |
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