PMA P950014S024

Device: PROSTATRON
Applicant: Urologix, Inc.
PMA number: P950014
Supplement: S024
Product code: MEQ
Decision date: 2005-02-23
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL TO CHANGE LOCATION BALLOON MATERIAL FROM LATEX TO SILICONE, TO CHANGE THE METHOD OF ATTACHING THE LOCATION BALLOON DUE TO THE NEW MATERIAL, AND TO REMOVE THE CURRENT LATEX SENSITIVITY CAUTION AND OTHER REFERENCES TO LATEX IN THE LABELING.

Current openFDA PMA Record#

Device: PROSTATRON
Applicant: Urologix, Inc.
PMA number: P950014
Supplement: S024
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2005-02-23
Decision code: APPR
Date received: 2005-01-19
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO CHANGE LOCATION BALLOON MATERIAL FROM LATEX TO SILICONE, TO CHANGE THE METHOD OF ATTACHING THE LOCATION BALLOON DUE TO THE NEW MATERIAL, AND TO REMOVE THE CURRENT LATEX SENSITIVITY CAUTION AND OTHER REFERENCES TO LATEX IN THE LABELING.