PMA P020012S015
- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S015
- Product code
- LMH
- Decision date
- 2017-09-28
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Removal of redundant quality control tests for SAN 8250 In-Process Tests with respect to PMMA.
Current openFDA PMA Record#
- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S015
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2017-09-28
- Decision code
- OK30
- Date received
- 2017-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of redundant quality control tests for SAN 8250 In-Process Tests with respect to PMMA.