- Device
- Revanesse Versa, Revanesse Versa+, Revanesse Lips+
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S015
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-04-16
- Decision code
- APPR
- Date received
- 2021-03-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes to post-market surveillance information of Revanesse Versa, Revanesse Versa+, and Revanesse Lips+.