|
Device | TMX-2000 THERMATRX OFFICE THERMO THERAPY 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 | S015 |
Date Received | 07/19/2006 |
Decision Date | 12/15/2006 |
Withdrawal Date
|
12/20/2016 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING TO INCORPORATE THE RESULTS OF THE 5-YEAR POSTAPPROVAL STUDY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH OF 25 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC. |