|
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 |
Supplement Number | S004 |
Date Received | 08/02/2002 |
Decision Date | 08/22/2002 |
Withdrawal Date
|
12/20/2016 |
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 REMOVE THE CONTRAINDICATION FOR PATIENTS WITH PROSTATIC OR BLADDER CANCER, AND ADD THE PRECAUTION STATING THAT THE SAFETY AND EFFECTIVENESS OF THE THERMATRX TMX-2000 HAS NOT BEEN ESTABLISHED IN PATIENTS WITH CLINICAL OR HISTOLOGICAL EVIDENCE OF PROSTATE OR BLADDER CANCER. |