Bellafill Dermal Filler
FDA premarket approval P020012/S014 · decided 2018-08-28
Approval details
- PMA number
- P020012
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Bellafill Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2017-06-15
- Decision date
- 2018-08-28
- Days to decision
- 439 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for changes to the 1mL syringe barrel material and changes to the syringe cap design and material supplier.
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