PMA P040024S115
- Device
- RESTYLANE INJECTABLE GELS
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S115
- Product code
- LMH
- Decision date
- 2019-09-30
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the removal of testing of heavy metals in raw materials as per USP<231> and replacing it by a risk analysis on the final product based on ICH Q3D guideline for Elemental Impurities for Restylane Injectable Gels
Current openFDA PMA Record#
- Device
- RESTYLANE INJECTABLE GELS
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S115
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-09-30
- Decision code
- APPR
- Date received
- 2019-07-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the removal of testing of heavy metals in raw materials as per USP and replacing it by a risk analysis on the final product based on ICH Q3D guideline for Elemental Impurities for Restylane Injectable Gels