PMA P140029S046
- Device
- RESTYLANE® Family of Injectable Gels
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S046
- Product code
- LMH
- Decision date
- 2022-10-04
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Changes to the WFI3 distribution system.
Current openFDA PMA Record#
- Device
- RESTYLANE® Family of Injectable Gels
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S046
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-10-04
- Decision code
- OK30
- Date received
- 2022-09-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the WFI3 distribution system.