PMA P950014S003

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S003
Product code
MEQ
Decision date
1996-12-27
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(TM) POSTAPPROVAL STUDY CASE REPORT FORM.

Current openFDA PMA Record#

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S003
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
1996-12-27
Decision code
APPR
Date received
1996-09-23
Supplement type
Normal 180 Day Track
Supplement reason
Other
Approval order statement
APPROVAL FOR CHANGES TO THE PROSTATRON(TM) POSTAPPROVAL STUDY CASE REPORT FORM.