STORMER ZIPPER MX BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Approval P790017 S077

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 stormer balloon dilatation catheter with zipper delivery, which is indicated for balloon dilatation of the stenoic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

DeviceSTORMER ZIPPER MX BALLOON DILATATION CATHETER
Classification NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantMEDTRONIC IRELAND
Date Received2002-04-01
Decision Date2002-09-18
PMAP790017
SupplementS077
Product CodeLOX
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC IRELAND parkmore Business Park West galway 

Supplemental Filings

Supplement NumberDateSupplement Type
P790017Original Filing
S110 2010-10-01 30-day Notice
S109 2010-08-16 30-day Notice
S108 2010-06-04 30-day Notice
S107 2010-03-22 30-day Notice
S106 2010-03-16 135 Review Track For 30-day Notice
S105
S104 2009-12-24 135 Review Track For 30-day Notice
S103 2009-11-19 30-day Notice
S102 2009-11-09 Normal 180 Day Track No User Fee
S101 2009-10-13 30-day Notice
S100 2009-01-26 Normal 180 Day Track No User Fee
S099 2008-12-16 30-day Notice
S098 2008-11-05 Normal 180 Day Track No User Fee
S097 2008-05-01 Normal 180 Day Track No User Fee
S096 2008-03-31 Normal 180 Day Track
S095 2008-03-31 Normal 180 Day Track
S094 2008-03-24 135 Review Track For 30-day Notice
S093 2007-11-13 30-day Notice
S092 2007-08-01 30-day Notice
S091 2007-08-01 30-day Notice
S090
S089
S088 2007-07-30 30-day Notice
S087 2007-07-23 30-day Notice
S086 2006-12-04 135 Review Track For 30-day Notice
S085 2006-04-17 Special (immediate Track)
S084 2005-09-23 30-day Notice
S083 2004-12-10 Real-time Process
S082 2004-04-05 Real-time Process
S081 2003-12-26 Real-time Process
S080 2003-04-30 30-day Notice
S079 2003-01-16 Real-time Process
S078 2002-12-18 Normal 180 Day Track
S077 2002-04-01 Normal 180 Day Track
S076 2001-11-05 Normal 180 Day Track
S075 2001-03-29 Real-time Process
S074 2000-09-14 Real-time Process
S073 2000-08-28 Normal 180 Day Track
S072 2000-07-14 30-day Notice
S071 2000-03-01 Normal 180 Day Track
S070
S069 1998-12-01 Normal 180 Day Track
S068 1998-12-10 30-day Notice
S067 1998-03-23 Normal 180 Day Track
S066 1998-04-01 Real-time Process
S065 1998-02-12 Real-time Process
S064 1998-01-20 Real-time Process
S063 1997-07-31 Real-time Process
S062 1997-05-30 Normal 180 Day Track
S061 1997-01-27 Real-time Process
S060 1996-12-17 Normal 180 Day Track
S059 1996-02-28 Normal 180 Day Track
S058 1995-10-03 Normal 180 Day Track
S057 1995-09-20 Normal 180 Day Track
S056 1995-04-10 30-Day Supplement
S055
S054
S053
S052 1993-06-23 Normal 180 Day Track
S051
S050
S049 1992-12-23 Normal 180 Day Track
S048
S047 1992-07-22 Normal 180 Day Track
S046 1992-06-29 Normal 180 Day Track
S045 1991-04-03 Normal 180 Day Track
S044 1992-03-03 Normal 180 Day Track
S043 1992-01-13 Normal 180 Day Track
S042
S041 1991-11-19 Normal 180 Day Track
S040 1991-02-21 Normal 180 Day Track
S039 1991-01-11 Normal 180 Day Track
S038
S037
S036
S035
S034
S033
S032
S031 1989-07-18 Normal 180 Day Track
S030
S029
S028 1989-05-26 Normal 180 Day Track
S027 1989-04-21 Normal 180 Day Track
S026 1989-04-06 Normal 180 Day Track
S025 1988-11-14 Normal 180 Day Track
S024
S023
S022 1988-08-29 Normal 180 Day Track
S021 1988-03-31 Special (immediate Track)
S020 1988-03-11 Normal 180 Day Track
S019 1988-01-22 Normal 180 Day Track
S018 1987-12-22 Normal 180 Day Track
S017 1987-11-18 Normal 180 Day Track
S016 1987-10-23 Normal 180 Day Track
S015 1987-07-15 Normal 180 Day Track
S014
S013 1987-02-02 Normal 180 Day Track
S012 1986-10-03 Normal 180 Day Track
S011 1985-06-14
S010
S009 1984-01-19
S008 1983-10-12 Normal 180 Day Track
S007 1983-07-22
S006 1982-11-05
S005 1982-10-25
S004 1982-05-18
S003 1981-08-04
S002 1981-08-04
S001 1980-12-22 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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