PMA P970008S062
- Device
- TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S062
- Product code
- MEQ
- Decision date
- 2012-12-20
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- IMPLEMENTATION OF ALTERNATIVE POUCH SEALING EQUIPMENT FOR PACKAGING A COMPONENT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S062
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2012-12-20
- Decision code
- OK30
- Date received
- 2012-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF ALTERNATIVE POUCH SEALING EQUIPMENT FOR PACKAGING A COMPONENT OF THE DEVICE.