PMA P950014S002

Device
MOBILE PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S002
Product code
MEQ
Decision date
1996-10-16
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
APPROVAL FOR A MOBILE VERSION OF THE PROSTATRON

Current openFDA PMA Record#

Device
MOBILE PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S002
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
1996-10-16
Decision code
APPR
Date received
1996-07-24
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR A MOBILE VERSION OF THE PROSTATRON