Note: 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. |
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Device | UROVYSION BLADDER CANCER KIT |
Generic Name | Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence |
Applicant | ABBOTT MOLECULAR 1300 E. Touhy Avenue Des Plaines, IL 60018 |
PMA Number | P030052 |
Supplement Number | S001 |
Date Received | 06/20/2005 |
Decision Date | 05/10/2006 |
Product Code |
NSD |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT DES PLAINES, DES PLAINES, ILLINOIS. |
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