Revanesse Versa; Revanesse Versa+ with Lidocaine; Revanesse Versa+ with Lidocaine 1.2 mL; Revanesse Versa 1.2 mL, Revan
FDA premarket approval P160042/S025 · decided 2024-06-11
Approval details
- PMA number
- P160042
- Supplement
- S025
- Supplement type
- 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, Revan
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2024-05-17
- Decision date
- 2024-06-11
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- for a change in the packaging equipment that is used to package the 1.0 mL and 1.2 mL configurations of Revanesse Versa, Revanesse Versa+ with Lidocaine, and Revanesse Lips+ with Lidocaine.
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