- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S038
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-05-14
- Decision code
- OK30
- Date received
- 2021-04-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new chromatography equipment for hydroxyproline/collagen content and lidocaine hydrochloride content in-process and lot release quality control testing.