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 (TM) SYSTEM DISPOSABLE TREATMENT APPLICATOR |
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 | S021 |
Date Received | 07/02/2001 |
Decision Date | 09/19/2001 |
Withdrawal Date
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12/30/2014 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT VENUSA DE MEXICO S.A. DE C.V, CHIHUAHUA, MEXICO, IN WHICH THE PROSTATRON DISPOSABLE TREATMENT APPLICATOR WILL BE ASSEMBLED. IN ADDITION, APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT VENUSA LTD., EL PASO, TEXAS, FOR THE RECEIPT, INSPECTION, STORAGE, AND RELEASE OF COMPONENTS AND THE QUARANTINE OF FINISHED STERILIZED DEVICES. ALSO, THE APPLICATOR WILL BE STERILIZED AT GRIFFITH MICROSCIENCE, SANTA TERESA, NEW MEXICO. |
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