Revanesse Versa, Revanesse Versa+ and Revanesse Lips+
FDA premarket approval P160042/S026 · decided 2024-07-12
Approval details
- PMA number
- P160042
- Supplement
- S026
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Revanesse Versa, Revanesse Versa+ and Revanesse Lips+
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2024-06-14
- Decision date
- 2024-07-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for standardizing the descriptive information about the cross-linked hyaluronic acid concentration on the box labels and in the professional directions for use.
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