Revanesse Versa, Revanesse Versa+ (with lidocaine), Revanesse Lips+ (with lidocaine)
FDA premarket approval P160042/S016 · decided 2024-06-21
Approval details
- PMA number
- P160042
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Revanesse Versa, Revanesse Versa+ (with lidocaine), Revanesse Lips+ (with lidocaine)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2021-07-16
- Decision date
- 2024-06-21
- Days to decision
- 1071 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for the qualification of hyaluronic acid (HA) from a new supplier.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.