Revanesse Versa; Revanesse Versa+ with Lidocaine, Revanesse Versa+ with Lidocaine 1.2 mL, Revanesse® Versa 1.2 mL, Reva
FDA premarket approval P160042/S024 · decided 2024-08-20
Approval details
- PMA number
- P160042
- Supplement
- S024
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Revanesse Versa; Revanesse Versa+ with Lidocaine, Revanesse Versa+ with Lidocaine 1.2 mL, Revanesse® Versa 1.2 mL, Reva
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2024-03-07
- Decision date
- 2024-08-20
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for the addition of a mixer discharger and piston mill for the milling of the subject device gels.
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