PMA P160042S032

Device: Revanesse Versa, Revanesse Versa+ (with lidocaine) and Revanesse Lips+ (with lidocaine)
Applicant: Prollenium Medical Technologies, Inc.
PMA number: P160042
Supplement: S032
Product code: LMH
Decision date: 2026-10-14
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval to qualify a Third-Party Logistics (3PL) supplier for warehousing and temperature-controlled storage of Revanesse Versa, Revanesse Versa+, and Revanesse Lips+ finished products

Current openFDA PMA Record#

Device: Revanesse Versa, Revanesse Versa+ (with lidocaine) and Revanesse Lips+ (with lidocaine)
Applicant: Prollenium Medical Technologies, Inc.
PMA number: P160042
Supplement: S032
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-10-14
Decision code: OK30
Date received: 2026-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to qualify a Third-Party Logistics (3PL) supplier for warehousing and temperature-controlled storage of Revanesse Versa, Revanesse Versa+, and Revanesse Lips+ finished products