Revanesse Ultra (Revanesse Versa)
FDA premarket approval P160042/S001 · decided 2017-10-02
Approval details
- PMA number
- P160042
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Revanesse Ultra (Revanesse Versa)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2017-08-14
- Decision date
- 2017-10-02
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for a name change from Revanesse Ultra to Revanesse Versa.
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