Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL)
FDA premarket approval P160042/S017 · decided 2022-04-20
Approval details
- PMA number
- P160042
- Supplement
- S017
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2021-10-05
- Decision date
- 2022-04-20
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for a change to the sample preparation in the Lidocaine HCl assay
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