cobas® EZH2 Mutation Test

FDA Premarket Approval P200014 S001

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

Manufacturing process change to use an alternate filter

Devicecobas® EZH2 Mutation Test
Generic NameSomatic Gene Mutation Detection System
ApplicantRoche Molecular System, Inc.
Date Received2020-07-27
Decision Date2020-08-26
PMAP200014
SupplementS001
Product CodeOWD 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular System, Inc. 4300 Hacienda Drive pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P200014Original Filing
S001 2020-07-27 30-day Notice

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