PMA P020012S040
- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S040
- Product code
- LMH
- Decision date
- 2022-01-21
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval to add an alternate supplier for NaOH used in the manufacture of the device.
Current openFDA PMA Record#
- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S040
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-01-21
- Decision code
- APPR
- Date received
- 2021-08-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add an alternate supplier for NaOH used in the manufacture of the device.