PMA P140029S037
- Device
- Restylane Kysse Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S037
- Product code
- LMH
- Decision date
- 2021-04-14
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Changes in the dialysis procedure for the manufacturing of Restylane Kysse to permit parallel dialysis of two batches of the same product at the same time.
Current openFDA PMA Record#
- Device
- Restylane Kysse Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S037
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-04-14
- Decision code
- OK30
- Date received
- 2021-03-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes in the dialysis procedure for the manufacturing of Restylane Kysse to permit parallel dialysis of two batches of the same product at the same time.