|
Device | RESTYLANE INJECTABLE GELS |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S035 |
Date Received | 02/09/2009 |
Decision Date | 03/05/2009 |
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 AS FOLLOWS: 1) ADD A NEW RAW MATERIAL SUPPLIER; 2) CHANGE THE SITE FOR RAW MATERIAL QUALITY ASSURANCE TESTING TO Q-MED AB; 3) ADD A HEAVY METALS TEST FOR RAW MATERIALS; AND 4) MODIFY A TEST METHOD FOR THE QUALITY CONTROL OF THE FINISHED PRODUCT. |