cobas HPV

FDA Premarket Approval P190028 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

Change of a suppliers manufacturing site for a critical component.

Devicecobas HPV
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantRoche Molecular Systems, Inc.
Date Received2020-04-10
Decision Date2020-05-05
PMAP190028
SupplementS001
Product CodeMAQ 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P190028Original Filing
S001 2020-04-10 30-day Notice

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