PMA P950014S006
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S006
- Product code
- MEQ
- Decision date
- 1997-11-24
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- Approval for changes to the Prostatron(R) software program to include a high energy treatment protocol (using either the single or dual-module hardware configurations).
Current openFDA PMA Record#
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S006
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1997-11-24
- Decision code
- APPR
- Date received
- 1997-04-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Prostatron(R) software program to include a high energy treatment protocol (using either the single or dual-module hardware configurations).