|
Device | RESTYLANE |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 SE-752 28 UPPSALA SE-75-752- |
PMA Number | P020023 |
Supplement Number | S009 |
Date Received | 07/09/2004 |
Decision Date | 08/06/2004 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR INCREASING THE EXPIRATION DATING FOR RESTYLANE FROM 24 MONTHS TO 36 MONTHS. |