PMA P950014S019
- Device
- PROSTATRON PRAKTIS
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S019
- Product code
- MEQ
- Decision date
- 1999-11-05
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- Approval for 1) disabling the hardware that controls the minimum coolant temperature, and 2) modifying the maximum microwave power rating on the faceplate label.
Current openFDA PMA Record#
- Device
- PROSTATRON PRAKTIS
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S019
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1999-11-05
- Decision code
- APPR
- Date received
- 1999-11-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for 1) disabling the hardware that controls the minimum coolant temperature, and 2) modifying the maximum microwave power rating on the faceplate label.