Revanesse Versa, Revanesse Versa+ with Lidocaine, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.2 mL, Revane
FDA premarket approval P160042/S020 · decided 2023-03-22
Approval details
- PMA number
- P160042
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Revanesse Versa, Revanesse Versa+ with Lidocaine, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.2 mL, Revane
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2023-02-21
- Decision date
- 2023-03-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Change to the stopper, which is a component of the syringe system of the 1.0 and 1.2mL configurations of Revanesse Versa, Revanesse Versa+ with Lidocaine, and Revanesse Lips+ with Lidocaine.
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