- Device
- Revanesse Versa / Revanesse Versa+ (with lidocaine) / Revanesse Lips+ (with lidocaine)
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S031
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-05-08
- Decision code
- OK30
- Date received
- 2026-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- new polyvinyl chloride material used in secondary packaging for Revanesse Versa, Revanesse Versa+, and Revanesse Lips+ product lines