|
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 | S006 |
Date Received | 04/19/2004 |
Decision Date | 05/10/2004 |
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 CHANGES IN INCREASING UTILIZATION FOR SOME OF THE MANUFACTURING PROCESS EQUIPMENT. |