PMA P040024S148
- Device
- RESTYLANE INJECTABLE GEL
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S148
- Product code
- LMH
- Decision date
- 2026-03-12
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- changes in analytical test methods used in the quality control testing of finished product.
Current openFDA PMA Record#
- Device
- RESTYLANE INJECTABLE GEL
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S148
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-03-12
- Decision code
- OK30
- Date received
- 2026-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes in analytical test methods used in the quality control testing of finished product.