Revanesse Versa, Revanesse Versa+, Revanesse Lips+

FDA Premarket Approval P160042 S015

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

Approval for labeling changes to post-market surveillance information of revanesse versa, revanesse versa+, and revanesse lips+.

DeviceRevanesse Versa, Revanesse Versa+, Revanesse Lips+
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantPROLLENIUM MEDICAL TECHNOLOGIES INC.
Date Received2021-03-17
Decision Date2021-04-16
PMAP160042
SupplementS015
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 Industrial Parkway North aurora L4G 4

Supplemental Filings

Supplement NumberDateSupplement Type
P160042Original Filing
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 IDPMASupp
66980800001000 P160042 000
66980800001017 P160042 003
66980800001024 P160042 004

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