PMA P970008S041

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S041
Product code
MEQ
Decision date
2008-12-09
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
MINOR CHANGES IN THE MANUFACTURING OF THE DIAPHRAGM SEAL.

Current openFDA PMA Record#

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S041
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2008-12-09
Decision code
OK30
Date received
2008-11-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MINOR CHANGES IN THE MANUFACTURING OF THE DIAPHRAGM SEAL.