Revanesse Versa, Revanesse Versa +

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P160042 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

The increase in syringe volume from 1. 0 ml to 1. 2 ml of revanesse versa and revanesse versa+

• Device: Revanesse Versa, Revanesse Versa +
• Classification Name: Implant, Dermal, For Aesthetic Use
• Generic Name: Implant, Dermal, For Aesthetic Use
• Applicant: PROLLENIUM MEDICAL TECHNOLOGIES INC.
• Date Received: 2018-05-29
• Decision Date: 2019-03-15
• PMA: P160042
• Supplement: S004
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 Industrial Parkway North aurora L4G 4

Supplemental Filings

Supplement Number	Date	Supplement Type
P160042		Original Filing
S017	2021-10-05	135 Review Track For 30-day Notice
S016
S015	2021-03-17	Special (immediate Track)
S014
S013
S012	2020-07-15	Real-time Process
S011	2020-01-22	Real-time Process
S010
S009	2019-05-06	30-day Notice
S008
S007
S006
S005
S004	2018-05-29	Normal 180 Day Track
S003	2017-12-20	Normal 180 Day Track
S002
S001	2017-08-14	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
66980800001000	P160042	000
66980800001017	P160042	003
66980800001024	P160042	004
10669808003032	P160042	014