Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL)

FDA Premarket Approval P160042 S017

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

DeviceRevanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL)
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantPROLLENIUM MEDICAL TECHNOLOGIES INC.138 Industrial Parkway Northaurora L4G 4 PMA NumberP160042 Supplement NumberS017 Date Received10/05/2021 Decision Date04/20/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2021-10-05
Decision Date2022-04-20
PMAP160042
SupplementS017
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressPROLLENIUM MEDICAL TECHNOLOGIES INC.
138 Industrial Parkway North
aurora L4G 4 PMA NumberP160042 Supplement NumberS017 Date Received10/05/2021 Decision Date04/20/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approval For A Change To The Sample Preparation In The Lidocaine HCl Assay

Supplemental Filings

Supplement NumberDateSupplement Type
P160042Original 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 IDPMASupp
66980800001000 P160042 000
66980800001017 P160042 003
66980800001024 P160042 004
10669808003032 P160042 014

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