PMA P160042S029

Device: Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)
Applicant: Prollenium Medical Technologies, Inc.
PMA number: P160042
Supplement: S029
Product code: LMH
Decision date: 2025-12-22
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: approval for modifications to cleanroom layout in a secondary manufacturing facility

Current openFDA PMA Record#

Device: Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)
Applicant: Prollenium Medical Technologies, Inc.
PMA number: P160042
Supplement: S029
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2025-12-22
Decision code: OK30
Date received: 2025-11-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for modifications to cleanroom layout in a secondary manufacturing facility