|
Device | THERMATRX 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 | S014 |
Date Received | 03/02/2006 |
Decision Date | 03/28/2006 |
Withdrawal Date
|
12/20/2016 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A TRANSFER OF PACKAGING SITE OF THE RECTAL PROBES TO AMERICAN MEDICAL SYSTEMS, MINNETONKA, MINNESOTA AND TO GENERATE PACKAGE LABELS IN HOUSE. |