UroVysion Bladder Cancer Kit

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Premarket Approval P030052 S021

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

Vendors relocation of a manufacturing site for production of reagents contained in kit components.

DeviceUroVysion Bladder Cancer Kit
Classification NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
Generic NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
Date Received2017-11-08
Decision Date2017-12-06
Product CodeNAH
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MOLECULAR 1300 E. Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P030052Original Filing
S028 2022-02-18 30-day Notice
S027 2020-11-16 30-day Notice
S026 2019-07-31 30-day Notice
S025 2019-04-10 30-day Notice
S024 2018-08-10 30-day Notice
S023 2018-06-15 30-day Notice
S022 2018-02-16 30-day Notice
S021 2017-11-08 30-day Notice
S020 2016-11-22 Real-time Process
S019 2016-09-12 30-day Notice
S018 2016-09-02 30-day Notice
S017 2015-11-12 135 Review Track For 30-day Notice
S016 2014-07-24 30-day Notice
S015 2014-06-16 30-day Notice
S014 2013-11-25 30-day Notice
S013 2013-11-05 30-day Notice
S012 2013-08-29 Normal 180 Day Track No User Fee
S011 2013-01-16 30-day Notice
S010 2012-10-25 Special (immediate Track)
S009 2012-07-13 30-day Notice
S008 2011-06-23 30-day Notice
S007 2011-05-06 30-day Notice
S006 2011-04-28 Special (immediate Track)
S005 2011-03-18 30-day Notice
S004 2011-02-25 Special (immediate Track)
S003 2009-01-26 30-day Notice
S002 2007-01-08 Real-time Process
S001 2005-06-20 Normal 180 Day Track No User Fee


Device IDPMASupp
00884999002180 P030052 001
00884999002142 P030052 001

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