|
Device | RESTYLANE INJECTABLE GEL |
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 | S002 |
Date Received | 01/20/2004 |
Decision Date | 02/13/2004 |
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 TWO MANUFACTURING CHANGES INVOLVING THE RESTYLANE PRODUCTION PROCESS. |