Revanesse Versa and Revanesse Versa+
FDA premarket approval P160042/S009 · decided 2019-06-04
Approval details
- PMA number
- P160042
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Revanesse Versa and Revanesse Versa+
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2019-05-06
- Decision date
- 2019-06-04
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Change to the Water For Injection System for Revanesse Versa and Revanesse Versa+.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.