Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | RESTYLANE INJECTABLE GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S041 |
Date Received | 06/10/2009 |
Decision Date | 07/10/2009 |
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 SANITATION CRITERIA FOR WATER FOR INJECTION (WFI), REDUCTION OF WATER SAMPLING FOR PURIFIED WATER (PW) AND WFI, AND REDUCTION OF FREQUENCY OF PERIODIC REVIEW OF UTILITY SYSTEMS. |
|
|