Revanesse Versa, Revanesse Versa+, Revanesse Lips+
FDA premarket approval P160042/S015 · decided 2021-04-16
Approval details
- PMA number
- P160042
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Revanesse Versa, Revanesse Versa+, Revanesse Lips+
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2021-03-17
- Decision date
- 2021-04-16
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for labeling changes to post-market surveillance information of Revanesse Versa, Revanesse Versa+, and Revanesse Lips+.
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