|
Device | TMX-2000 BPH 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 |
Date Received | 10/16/2000 |
Decision Date | 06/29/2001 |
Withdrawal Date
|
12/20/2016 |
Product Code |
MEQ |
Docket Number | 01M-0296 |
Notice Date | 07/16/2001 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE TMX-2000(TM) BPH THERMOTHERAPY SYSTEM. THE DEVICE IS INDICATED AS A NON-SURGICAL DEVICE FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH OF 30 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 |