PROSTATRON

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

FDA Premarket Approval P950014 S018

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 upgrades to the prostasoft software to version 4. 02.

DevicePROSTATRON
Classification NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
ApplicantUrologix, Inc.
Date Received1999-05-17
Decision Date1999-05-19
PMAP950014
SupplementS018
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.