PMA P140029S029
- Device
- Restylane Kysse Injectable Gel
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2020-12-21
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for a new alternative supplier for Lidocaine Hydrochloride (Lidocaine HCl) for Restylane Kysse
Current openFDA PMA Record#
- Device
- Restylane Kysse Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S029
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-12-21
- Decision code
- APPR
- Date received
- 2020-08-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new alternative supplier for Lidocaine Hydrochloride (Lidocaine HCl) for Restylane Kysse