PMA P950014S010

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S010
Product code
MEQ
Decision date
1997-10-07
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
Approval for a transmobile version fothe Prostatron (dual module version).

Current openFDA PMA Record#

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S010
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
1997-10-07
Decision code
APPR
Date received
1997-10-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a transmobile version fothe Prostatron (dual module version).