FDA Premarket Approval P030052

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the urovysion bladder cancer kit. The device is indicated for: the urovysion bladder cancer kit (urovysion kit) is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the urovysion kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

Date Received2003-12-10
Decision Date2005-01-24
Notice Date2005-04-12
Docket Number05M-0130
Advisory CommitteePathology
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MOLECULAR 1300 E. Touhy Avenue des Plaines, IL 60018
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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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