PROSTATRON

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

FDA Premarket Approval P950014 S009

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 the following changes in intended to minimize the risk of prostaprobe balloon deflation difficulty: 1)modification of the prostaprobe manufacturing procedures, and 2) addition of a labeling precaution.

DevicePROSTATRON
Classification NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
ApplicantUrologix, Inc.
Date Received1997-09-18
Decision Date1997-09-24
PMAP950014
SupplementS009
Product CodeMEQ
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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