CINtec PLUS Cytology

FDA Premarket Approval P190024 S002

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

Replacement of dispenser molds used in the injection molding process for six (6) dispenser parts

DeviceCINtec PLUS Cytology
Generic NameImmunocytochemistry Assay, P16/ki-67
ApplicantVentana Medical Systems, Inc.
Date Received2020-08-26
Decision Date2020-11-13
PMAP190024
SupplementS002
Product CodeQKF 
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
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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