Revanesse Lips+ with Lidocaine 1.2 mL
FDA premarket approval P160042/S023 · decided 2024-05-01
Approval details
- PMA number
- P160042
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Revanesse Lips+ with Lidocaine 1.2 mL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2024-02-02
- Decision date
- 2024-05-01
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval of additional real time stability data to fulfill the post approval requirement for the 24-month shelf-life of Revanesse Lips+ 1.2 mL
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