SPRINTER LEGEND RX BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Approval P790017 S107

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

Additional vendor for a component of the device.

DeviceSPRINTER LEGEND RX BALLOON DILATATION CATHETER
Classification NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantMEDTRONIC IRELAND
Date Received2010-03-22
Decision Date2010-04-21
PMAP790017
SupplementS107
Product CodeLOX
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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