PMA P950014S007

Device: PROSTATRON
Applicant: Urologix, Inc.
PMA number: P950014
Supplement: S007
Product code: MEQ
Decision date: 1997-10-27
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: Approval for a single-module version of the Prostatron, as well as minor hardware and software changes to both the single and dual-module Prostatron versions.

Current openFDA PMA Record#

Device: PROSTATRON
Applicant: Urologix, Inc.
PMA number: P950014
Supplement: S007
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 1997-10-27
Decision code: APPR
Date received: 1997-08-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a single-module version of the Prostatron, as well as minor hardware and software changes to both the single and dual-module Prostatron versions.