PMA P140029S057
- Device
- Restylane® Contour
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S057
- Product code
- LMH
- Decision date
- 2026-05-15
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the post-approval study protocol to evaluate the safety of re-treatment with Restylane Contour in the treatment of temple hollowing
Current openFDA PMA Record#
- Device
- Restylane® Contour
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S057
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-05-15
- Decision code
- APPR
- Date received
- 2026-04-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the post-approval study protocol to evaluate the safety of re-treatment with Restylane Contour in the treatment of temple hollowing