PMA P950014S013
- Device
- PROSTATRON MAXIS
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S013
- Product code
- MEQ
- Decision date
- 1998-03-10
- 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 addition of a barcode identification label to the Prostaprobe, and 2) modifications to the Prostatron(TM) Maxis and dual module configurations to require entry of the Prostaprobe barcode information prior to treatment.
Current openFDA PMA Record#
- Device
- PROSTATRON MAXIS
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S013
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1998-03-10
- Decision code
- APPR
- Date received
- 1998-03-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for 1) the addition of a barcode identification label to the Prostaprobe, and 2) modifications to the Prostatron(TM) Maxis and dual module configurations to require entry of the Prostaprobe barcode information prior to treatment.