UroVysion Bladder Cancer Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)

FDA Premarket Approval P030052 S025

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

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DeviceUroVysion Bladder Cancer Kit
Classification NameFluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)
Generic NameFluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)
Date Received2019-04-10
Decision Date2019-05-08
Product CodePNK
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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