PMA P970008
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S065
- Product code
- MEQ
- Decision date
- 2015-10-29
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT SPECTRUM PLASTICS GROUP IN MINNEAPOLIS, MINNESOTA.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S065
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2015-10-29
- Decision code
- APPR
- Date received
- 2015-09-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT SPECTRUM PLASTICS GROUP IN MINNEAPOLIS, MINNESOTA.