PMA P950014S004
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S004
- Product code
- MEQ
- Decision date
- 1996-10-29
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- UPGRADES IN 1)THE LUXTRON THERMOMETRY UNIT FROM MODEL 3000-4 TO MODEL 3100; 2) THE COMPUTER PROCESSOR FROM 386 TO PENTIUM; AND 3) THE SOFTWARE FROM VERSION 3.07 TO VERSION 3.09
Current openFDA PMA Record#
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S004
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1996-10-29
- Decision code
- APPR
- Date received
- 1996-10-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- UPGRADES IN 1)THE LUXTRON THERMOMETRY UNIT FROM MODEL 3000-4 TO MODEL 3100; 2) THE COMPUTER PROCESSOR FROM 386 TO PENTIUM; AND 3) THE SOFTWARE FROM VERSION 3.07 TO VERSION 3.09