PMA P970008S033
- Device
- TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S033
- Product code
- MEQ
- Decision date
- 2008-04-15
- 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 MANUFACTURING SITE LOCATED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA FOR THE MANUFACTURING OF THE COOLANT BAG KITS.
Current openFDA PMA Record#
- Device
- TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S033
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2008-04-15
- Decision code
- APPR
- Date received
- 2007-07-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA FOR THE MANUFACTURING OF THE COOLANT BAG KITS.