PROLIEVE THERMODILATATION SYSTEM

FDA Premarket Approval P030006 S004

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 a new ink to be used to mark the catheter component of the device using the same pad printing process for applying these markings.

DevicePROLIEVE THERMODILATATION SYSTEM
Generic NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
ApplicantMEDIFOCUS, INC
Date Received2005-01-28
Decision Date2005-03-11
PMAP030006
SupplementS004
Product CodeMEQ 
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MEDIFOCUS, INC 10240 Old Columbia Road suite G columbia, MD 21046

Supplemental Filings

Supplement NumberDateSupplement Type
P030006Original Filing
S028 2018-03-30 Normal 180 Day Track No User Fee
S027 2014-11-18 30-day Notice
S026 2014-05-21 135 Review Track For 30-day Notice
S025 2012-04-23 30-day Notice
S024 2010-12-23 Normal 180 Day Track No User Fee
S023 2010-01-13 30-day Notice
S022 2009-04-02 Normal 180 Day Track
S021 2009-01-16 135 Review Track For 30-day Notice
S020 2008-11-14 30-day Notice
S019 2008-07-01 Real-time Process
S018 2008-06-05 135 Review Track For 30-day Notice
S017 2008-02-12 Normal 180 Day Track
S016 2007-09-28 30-day Notice
S015 2007-06-14 30-day Notice
S014 2007-06-13 Real-time Process
S013 2007-04-23 Normal 180 Day Track No User Fee
S012 2006-11-21 Real-time Process
S011 2006-06-26 Real-time Process
S010 2005-12-01 Normal 180 Day Track No User Fee
S009 2005-11-21 Normal 180 Day Track
S008 2005-11-18 Normal 180 Day Track
S007 2005-09-12 30-day Notice
S006 2005-05-31 Real-time Process
S005 2005-03-23 Normal 180 Day Track No User Fee
S004 2005-01-28 Real-time Process
S003 2004-10-01 Normal 180 Day Track No User Fee
S002 2004-08-18 Real-time Process
S001 2004-03-11 Normal 180 Day Track No User Fee

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