Revanesse Versa+
FDA premarket approval P160042/S011 · decided 2020-04-21
Approval details
- PMA number
- P160042
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Revanesse Versa+
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2020-01-22
- Decision date
- 2020-04-21
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval of change of shelf-life from 12 months to 18 months for Revanesse Versa+.
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