PMA P970008S047
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S047
- Product code
- MEQ
- Decision date
- 2010-03-31
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- REMOVAL OF A QUALITY CONTROL TEST ON AN INCOMING RAW MATERIAL COMPONENT USED IN THE MANUFACTURE OF THE TREATMENT CATHETER.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S047
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2010-03-31
- Decision code
- OK30
- Date received
- 2010-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF A QUALITY CONTROL TEST ON AN INCOMING RAW MATERIAL COMPONENT USED IN THE MANUFACTURE OF THE TREATMENT CATHETER.