PMA P040024S136
- Device
- Restylane® Silk Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S136
- Product code
- LMH
- Decision date
- 2022-12-23
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for revisions to the clinician labeling and patient labeling of Restylane® Silk Injectable Gel as a result of postmarket surveillance data.
Current openFDA PMA Record#
- Device
- Restylane® Silk Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S136
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-12-23
- Decision code
- APPR
- Date received
- 2022-11-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the clinician labeling and patient labeling of Restylane® Silk Injectable Gel as a result of postmarket surveillance data.