BELLAFILL PMMA COLLAGEN DERMAL FILLER
FDA premarket approval P020012/S011 · decided 2015-08-07
Approval details
- PMA number
- P020012
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- BELLAFILL PMMA COLLAGEN DERMAL FILLER
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2015-02-24
- Decision date
- 2015-08-07
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT DESCRIBED THE RESULTS OF YOUR 5-YEAR POST-APPROVAL STUDY (P521-01).
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