PMA P970008S009
- Device
- RECTAL THERMOSENSING UNIT RTU
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S009
- Product code
- MEQ
- Decision date
- 1998-10-29
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- Approval for minor changes in the design and labeling of the Rectal Thermosensing Unit.
Current openFDA PMA Record#
- Device
- RECTAL THERMOSENSING UNIT RTU
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S009
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1998-10-29
- Decision code
- APPR
- Date received
- 1998-10-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor changes in the design and labeling of the Rectal Thermosensing Unit.