PROSTATRON PRAKTIS

System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy

FDA Premarket Approval P950014 S019

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for 1) disabling the hardware that controls the minimum coolant temperature, and 2) modifying the maximum microwave power rating on the faceplate label.

DevicePROSTATRON PRAKTIS
Classification NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
ApplicantUrologix, Inc.
Date Received1999-11-02
Decision Date1999-11-05
PMAP950014
SupplementS019
Product CodeMEQ
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Urologix, Inc. 14405 21st Avenue N. minneapolis, MN 55447-2000

Supplemental Filings

Supplement NumberDateSupplement Type
P950014Original Filing
S026 2008-03-14 Normal 180 Day Track
S025
S024 2005-01-19 Real-time Process
S023 2004-09-30 Normal 180 Day Track
S022 2004-05-17 Real-time Process
S021 2001-07-02 Normal 180 Day Track
S020 1999-11-26 Normal 180 Day Track
S019 1999-11-02 Real-time Process
S018 1999-05-17 Real-time Process
S017 1999-01-13 Real-time Process
S016 1998-06-25 Normal 180 Day Track
S015 1998-07-14 Normal 180 Day Track
S014 1998-06-09 Real-time Process
S013 1998-03-04 Real-time Process
S012 1998-01-14 Real-time Process
S011 1997-12-31 Normal 180 Day Track
S010 1997-10-01 Real-time Process
S009 1997-09-18 Real-time Process
S008 1997-08-28 Normal 180 Day Track
S007 1997-08-06 Normal 180 Day Track
S006 1997-04-07 Normal 180 Day Track
S005 1996-10-31 Special (immediate Track)
S004 1996-10-25 Real-time Process
S003 1996-09-23 Normal 180 Day Track
S002 1996-07-24 Normal 180 Day Track
S001 1996-05-16 Normal 180 Day Track

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