CINtec PLUS Cytology

FDA Premarket Approval P190024 S005

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

DeviceCINtec PLUS Cytology
Generic NameImmunocytochemistry Assay, P16/ki-67
ApplicantVentana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS005 Date Received01/28/2022 Decision Date06/10/2022 Product Code QKF  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-01-28
Decision Date2022-06-10
PMAP190024
SupplementS005
Product CodeQKF 
Advisory CommitteePathology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems, Inc.
1910 E Innovation Park Drive
tucson, AZ 85755 PMA NumberP190024 Supplement NumberS005 Date Received01/28/2022 Decision Date06/10/2022 Product Code QKF  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
addition Of Two New Contract Manufacturers As Approved Suppliers For Component Parts

Supplemental Filings

Supplement NumberDateSupplement Type
P190024Original Filing
S005 2022-01-28 135 Review Track For 30-day Notice
S004 2021-03-01 30-day Notice
S003
S002 2020-08-26 Real-time Process
S001 2020-04-28 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04015630977215 P190024 000

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