PMA P950014S020

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S020
Product code
MEQ
Decision date
2000-04-13
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
Approval for changes to the Prostatron software program to include the 30-Minute TUMT treatment protocol.

Current openFDA PMA Record#

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S020
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2000-04-13
Decision code
APPR
Date received
1999-11-26
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to the Prostatron software program to include the 30-Minute TUMT treatment protocol.