Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa + with Lidocaine 1.0 mL, Revanesse Versa + with Lidocain
FDA premarket approval P160042/S019 · decided 2024-03-01
Approval details
- PMA number
- P160042
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa + with Lidocaine 1.0 mL, Revanesse Versa + with Lidocain
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2022-05-02
- Decision date
- 2024-03-01
- Days to decision
- 669 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for the addition of a secondary manufacturing site and a sterilizer for the design, manufacturing and sterilization of Revanesse Versa, Revanesse Versa+ with lidocaine and Revanesse Lips+ with lidocaine in 1.0 mL and 1.2 mL configuration.
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