PMA P970008S022
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S022
- Product code
- MEQ
- Decision date
- 2002-08-01
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- CHANGE OF SUPPLIER FOR THE FIBER OPTIC TEMPERATURE SENSOR PROBE COMPONENT FROM THE LUXTRON CORPORATION IN SANTA CLARA, CALIFORNIA TO THE UROLOGIX FACILITY AND A CHANGE IN THE USE OF AN ADHESIVE BONDING PROCESS TO AN ANNEALING PROCESS ON THE COOLANT BAG.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S022
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2002-08-01
- Decision code
- OK30
- Date received
- 2002-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF SUPPLIER FOR THE FIBER OPTIC TEMPERATURE SENSOR PROBE COMPONENT FROM THE LUXTRON CORPORATION IN SANTA CLARA, CALIFORNIA TO THE UROLOGIX FACILITY AND A CHANGE IN THE USE OF AN ADHESIVE BONDING PROCESS TO AN ANNEALING PROCESS ON THE COOLANT BAG.