Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceUROVYSION BLADDER CANCER KIT
ApplicantABBOTT MOLECULAR
1300 E. Touhy Avenue
Des Plaines, IL 60018
PMA NumberP030052
Date Received12/10/2003
Decision Date01/24/2005
Docket Number 05M-0130
Notice Date 04/12/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 
-
-