Revanesse Versa, Revanesse Versa +
FDA premarket approval P160042/S004 · decided 2019-03-15
Approval details
- PMA number
- P160042
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Revanesse Versa, Revanesse Versa +
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2018-05-29
- Decision date
- 2019-03-15
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for the increase in syringe volume from 1.0 mL to 1.2 mL of Revanesse Versa and Revanesse Versa+.
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