PMA P040024S103
- Device
- RESTYLANE
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S103
- Product code
- LMH
- Decision date
- 2019-05-17
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for revisions to the clinician and patient labeling of Restylane to include updated safety information based on post marketing surveillance data.
Current openFDA PMA Record#
- Device
- RESTYLANE
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S103
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-05-17
- Decision code
- APPR
- Date received
- 2018-11-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the clinician and patient labeling of Restylane to include updated safety information based on post marketing surveillance data.