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 | S024 |
Date Received | 01/19/2005 |
Decision Date | 02/23/2005 |
Withdrawal Date
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12/30/2014 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CHANGE LOCATION BALLOON MATERIAL FROM LATEX TO SILICONE, TO CHANGE THE METHOD OF ATTACHING THE LOCATION BALLOON DUE TO THE NEW MATERIAL, AND TO REMOVE THE CURRENT LATEX SENSITIVITY CAUTION AND OTHER REFERENCES TO LATEX IN THE LABELING. |
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