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 | PROSTATRON |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Urologix, Inc. 14405 21ST AVENUE N. MINNEAPOLIS, MN 55447-2000 |
PMA Number | P950014 |
Supplement Number | S015 |
Date Received | 07/14/1998 |
Decision Date | 08/19/1998 |
Withdrawal Date
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12/30/2014 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for: 1) the use of an alternate thermometry system (Luxtron Model 3204), with related changes to the Prostaprobe and software; 2) the use of an upgraded microprocessor in the main computer; 3) a change of the material of several cabinet panels from metal to plastic; and 4) the addition of electromagnetic shielding to the cooling system regulation board. |
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