RF Conductr, RF Contactr, RF Marinr, RF Enhancr II

FDA Premarket Approval P930029 S066

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

To transfer the incoming inspection process sem/eds and ftir testing activities to the mproc juncos facility laboratories

DeviceRF Conductr, RF Contactr, RF Marinr, RF Enhancr II
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantMEDTRONIC Inc.
Date Received2020-07-02
Decision Date2020-07-23
PMAP930029
SupplementS066
Product CodeLPB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P930029Original Filing
S066 2020-07-02 30-day Notice
S065 2018-12-20 Normal 180 Day Track
S064 2018-12-07 30-day Notice
S063 2018-11-19 30-day Notice
S062
S061 2018-08-30 30-day Notice
S060 2018-06-01 30-day Notice
S059 2018-02-22 30-day Notice
S058 2018-01-16 Real-time Process
S057 2016-11-14 30-day Notice
S056
S055 2016-08-03 Real-time Process
S054 2015-12-28 30-day Notice
S053 2015-08-05 30-day Notice
S052 2015-07-23 Normal 180 Day Track No User Fee
S051 2015-04-17 30-day Notice
S050 2015-03-27 30-day Notice
S049 2014-12-24 Real-time Process
S048 2014-12-23 Real-time Process
S047 2014-12-18 Real-time Process
S046 2014-08-27 30-day Notice
S045
S044 2014-07-01 Real-time Process
S043 2014-05-05 30-day Notice
S042 2014-02-27 30-day Notice
S041 2014-02-11 30-day Notice
S040 2013-12-19 30-day Notice
S039 2013-03-22 30-day Notice
S038 2012-11-30 30-day Notice
S037 2012-11-21 30-day Notice
S036 2012-02-29 30-day Notice
S035 2011-11-25 30-day Notice
S034 2011-10-21 30-day Notice
S033 2011-07-18 30-day Notice
S032 2011-07-08 30-day Notice
S031 2011-06-08 30-day Notice
S030 2011-05-13 30-day Notice
S029 2011-04-26 30-day Notice
S028 2010-11-12 30-day Notice
S027 2010-10-26 30-day Notice
S026
S025 2010-07-15 30-day Notice
S024 2010-07-15 30-day Notice
S023 2010-06-28 135 Review Track For 30-day Notice
S022 2009-05-11 30-day Notice
S021 2003-12-10 Real-time Process
S020 2003-02-14 Real-time Process
S019 2002-12-16 Special (immediate Track)
S018 2002-11-04 Real-time Process
S017 2002-03-18 Real-time Process
S016
S015 2001-08-06 Real-time Process
S014 2000-06-28 Real-time Process
S013 2000-02-29 Normal 180 Day Track
S012 1998-06-30 Normal 180 Day Track
S011 1998-03-23 Normal 180 Day Track
S010 1997-11-04 Normal 180 Day Track
S009
S008 1996-12-26 Normal 180 Day Track
S007 1996-03-15 Normal 180 Day Track
S006 1995-11-03 Normal 180 Day Track
S005 1995-09-25 Normal 180 Day Track
S004 1995-08-30 Special (immediate Track)
S003 1995-04-14 Special (immediate Track)
S002 1995-03-20 Normal 180 Day Track
S001 1995-02-15 Normal 180 Day Track

NIH GUDID Devices

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