|
Device | RESTYLANE-L |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S088 |
Date Received | 10/29/2015 |
Decision Date | 11/23/2015 |
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 ADDITIONAL LANGUAGE IN PATIENT AND PROVIDER LABELING REGARDING THE RISK OF INTRAVASCULAR INJECTION OF SOFT TISSUE FILLERS. |