PMA P140029S038
- Device
- Restylane Kysse Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S038
- Product code
- LMH
- Decision date
- 2021-04-13
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Revision of the criteria for the visual inspection of filled and sterilized syringes performed during manufacturing.
Current openFDA PMA Record#
- Device
- Restylane Kysse Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S038
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-04-13
- Decision code
- OK30
- Date received
- 2021-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revision of the criteria for the visual inspection of filled and sterilized syringes performed during manufacturing.