|
Device | RESTYLANE L AND PERLANE L INJECTABLE GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S062 |
Date Received | 07/13/2012 |
Decision Date | 08/06/2012 |
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 | Yes |
Approval Order Statement APPROVAL FOR AN EXTENSION TO THE EXPIRATION DATE OF THE RESTYLANE L AND PERLANE L INJECTABLE GELS (0.5 AND 1.0 ML) FROM 24 MONTHS TO 36 MONTHS. |