CINtec PLUS Cytology

FDA Premarket Approval P190024 S006

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 NameTumor Gene Profiling Test
ApplicantVentana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS006 Date Received02/16/2022 Decision Date07/21/2022 Product Code QFK  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-02-16
Decision Date2022-07-21
PMAP190024
SupplementS006
Product CodeQFK 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems, Inc.
1910 E Innovation Park Drive
tucson, AZ 85755 PMA NumberP190024 Supplement NumberS006 Date Received02/16/2022 Decision Date07/21/2022 Product Code QFK  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For (i) A Change In Expiry Dating From Hematoxylin And Hematoxylin II And (ii) Implementation Of A Revised Process For Creating Reference Slides Used In Surveillance And Stability Testing Of Hematoxylin And Hematoxylin II

Supplemental Filings

Supplement NumberDateSupplement Type
P190024Original Filing
S007 2022-07-12 30-day Notice
S006 2022-02-16 Special (immediate Track)
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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