|
Device | RESTYLANE REFYNE and RESTYLANE DEFYNE |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB Seminariegatan 21 Uppsala S-752-7522 |
PMA Number | P140029 |
Supplement Number | S015 |
Date Received | 10/22/2018 |
Decision Date | 11/19/2018 |
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 | Yes |
Approval Order Statement Change in the manufacturing procedure/introduction of an In-Process Control (IPC) used in the bulk process for Restylane Refyne and Restylane Defyne. |