PMA P020012
- Device
- SANAE®
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S041
- Product code
- LMH
- Decision date
- 2026-08-07
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval to change the device trade name from Bellafill® to SANAE®
Current openFDA PMA Record#
- Device
- SANAE®
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S051
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-08-07
- Decision code
- APPR
- Date received
- 2026-03-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to change the device trade name from Bellafill® to SANAE®