PMA P950014S001

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S001
Product code
MEQ
Decision date
1996-06-20
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
APPROVAL TO SUPPLY THE PROSTATRON TREATMENT CATHETER (I.E., THE PROSTAPROBE) IN STERILE FORM

Current openFDA PMA Record#

Device
PROSTATRON
Applicant
Urologix, Inc.
PMA number
P950014
Supplement
S001
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
1996-06-20
Decision code
APPR
Date received
1996-05-16
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL TO SUPPLY THE PROSTATRON TREATMENT CATHETER (I.E., THE PROSTAPROBE) IN STERILE FORM