PMA P040024S117
- Device
- Restylane Injectable Gels
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2020-10-01
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the addition of an alternate qualified supplier for Lidocaine HCl.
Current openFDA PMA Record#
- Device
- Restylane Injectable Gels
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S117
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-10-01
- Decision code
- APPR
- Date received
- 2019-09-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of an alternate qualified supplier for Lidocaine HCl.