PMA P040024S113
- Device
- RESTYLANE NASHA
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S113
- Product code
- LMH
- Decision date
- 2019-06-20
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Outsourcing the method of analysis for D-value determination of biological indicators produced by Galderma Uppsala, Sweden.
Current openFDA PMA Record#
- Device
- RESTYLANE NASHA
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S113
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-06-20
- Decision code
- OK30
- Date received
- 2019-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Outsourcing the method of analysis for D-value determination of biological indicators produced by Galderma Uppsala, Sweden.