PMA P970008S056

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S056
Product code
MEQ
Decision date
2011-04-29
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
CHANGES IN THE QUALITY CONTROL TESTING.

Current openFDA PMA Record#

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S056
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2011-04-29
Decision code
OK30
Date received
2011-04-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES IN THE QUALITY CONTROL TESTING.