PMA P020012S031
- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S031
- Product code
- LMH
- Decision date
- 2019-07-08
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Lowering the manufacturing water for injection (WFI) tank and loop system alert temperature from 80 degree C to 70 degree C.
Current openFDA PMA Record#
- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S031
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-07-08
- Decision code
- OK30
- Date received
- 2019-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Lowering the manufacturing water for injection (WFI) tank and loop system alert temperature from 80 degree C to 70 degree C.