Revanesse Versa +
FDA premarket approval P160042/S003 · decided 2018-08-02
Approval details
- PMA number
- P160042
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Revanesse Versa +
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2017-12-20
- Decision date
- 2018-08-02
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for the addition of lidocaine to the formulation of Revanesse Versa.
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