Revanesse Versa, Revanesse Versa + (with lidocaine), Revanesse Lips+ (with lidocaine)
FDA premarket approval P160042/S013 · decided 2022-02-08
Approval details
- PMA number
- P160042
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Revanesse Versa, Revanesse Versa + (with lidocaine), Revanesse Lips+ (with lidocaine)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2020-11-02
- Decision date
- 2022-02-08
- Days to decision
- 463 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for a change in syringe for Revanesse Versa, Revanesse Versa+, and Revanesse Lips+.
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