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 MAXIS |
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 | S013 |
Date Received | 03/04/1998 |
Decision Date | 03/10/1998 |
Withdrawal Date
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12/30/2014 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for 1) the addition of a barcode identification label to the Prostaprobe, and 2) modifications to the Prostatron(TM) Maxis and dual module configurations to require entry of the Prostaprobe barcode information prior to treatment. |
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