PMA P970008S051

Device
UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S051
Product code
MEQ
Decision date
2010-07-16
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
CHANGE IN THE SUPPLIER OF SOLDER USED IN THE MANUFACTURE OF THE TARGIS SHORT CATHETER.

Current openFDA PMA Record#

Device
UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S051
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2010-07-16
Decision code
OK30
Date received
2010-07-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE SUPPLIER OF SOLDER USED IN THE MANUFACTURE OF THE TARGIS SHORT CATHETER.