PMA P950014S014

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S014
Product code
MEQ
Decision date
1998-06-09
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
Approval for an upgrade to the Prostatron's (TM) operating software to Prostasoft 4.0 (aslo referred to as "Prostasoft 98").

Current openFDA PMA Record#

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S014
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
1998-06-09
Decision code
APPR
Date received
1998-06-09
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an upgrade to the Prostatron's (TM) operating software to Prostasoft 4.0 (aslo referred to as "Prostasoft 98").