PMA P020012S041
- Device
- Bellafill® Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S041
- Product code
- LMH
- Decision date
- 2022-08-05
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Implementing an alternate particle testing method as the primary test method for PMMA microsphere count and size distribution testing.
Current openFDA PMA Record#
- Device
- Bellafill® Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S041
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-08-05
- Decision code
- OK30
- Date received
- 2022-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementing an alternate particle testing method as the primary test method for PMMA microsphere count and size distribution testing.