PMA P970008S044

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S044
Product code
MEQ
Decision date
2009-06-24
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
ADDITION OF AN ADHESIVE TO THE MANUFACTURING OF A CONTROL UNIT.

Current openFDA PMA Record#

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S044
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2009-06-24
Decision code
OK30
Date received
2009-06-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN ADHESIVE TO THE MANUFACTURING OF A CONTROL UNIT.