|
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 | S124 |
Date Received | 07/28/2021 |
Decision Date | 10/22/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to change the bacterial endotoxin specification limit of the Terumo needle co-packed with RESTYLANE® Injectable Gels. |