|
Device | RESTYLANE AND PERLANE INJECTABLE GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S037 |
Date Received | 03/17/2009 |
Decision Date | 04/08/2009 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES IN THE SUPPLIER OF 1.2 M HYDROCHLORIC ACID AND 0.25 M SODIUM HYDROXIDE SOLUTIONS. |