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 | TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P000043 |
Supplement Number | S010 |
Date Received | 01/17/2006 |
Decision Date | 02/08/2007 |
Withdrawal Date
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12/20/2016 |
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 AN UPGRADE OF THE DEVICE INCLUDING A MODIFICATION OF THE MAIN CONSOLE, COMPUTER AND SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH F 25 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC. |
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