CINtec PLUS Cytology

FDA Premarket Approval P190024 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

Modification of a method for preparing qualified samples used in qc testing

DeviceCINtec PLUS Cytology
Generic NameImmunocytochemistry Assay, P16/ki-67
ApplicantVentana Medical Systems, Inc.
Date Received2021-03-01
Decision Date2021-03-29
PMAP190024
SupplementS004
Product CodeQKF 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Ventana Medical Systems, Inc. 1910 E Innovation Park Drive tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P190024Original Filing
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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