PMA P950014S015
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S015
- Product code
- MEQ
- Decision date
- 1998-08-19
- 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) the use of an alternate thermometry system (Luxtron Model 3204), with related changes to the Prostaprobe and software; 2) the use of an upgraded microprocessor in the main computer; 3) a change of the material of several cabinet panels from metal to plastic; and 4) the addition of electromagnetic shielding to the cooling system regulation board.
Current openFDA PMA Record#
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S015
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1998-08-19
- Decision code
- APPR
- Date received
- 1998-07-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for: 1) the use of an alternate thermometry system (Luxtron Model 3204), with related changes to the Prostaprobe and software; 2) the use of an upgraded microprocessor in the main computer; 3) a change of the material of several cabinet panels from metal to plastic; and 4) the addition of electromagnetic shielding to the cooling system regulation board.