Catheter RF Contactr, Catheter RF Enhancr II, RF Conductr MC, RF Marinr, RF Marinr 5F SC/ 5F SCXL, 5F SCXS and 5F SCXXL,

FDA Premarket Approval P930029 S068

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 update the manufacturing execution system to factoryworks release 9. 8

DeviceCatheter RF Contactr, Catheter RF Enhancr II, RF Conductr MC, RF Marinr, RF Marinr 5F SC/ 5F SCXL, 5F SCXS and 5F SCXXL,
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantMEDTRONIC Inc.
Date Received2020-11-24
Decision Date2020-12-15
PMAP930029
SupplementS068
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
S071 2022-05-20 30-day Notice
S070 2021-11-18 30-day Notice
S069 2020-11-27 30-day Notice
S068 2020-11-24 30-day Notice
S067 2020-08-31 30-day Notice
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

Device IDPMASupp
00681490024358 P930029 000
00613994947246 P930029 002
00613994947260 P930029 008
00613994947369 P930029 008
00613994947314 P930029 008
00613994947321 P930029 008
00613994947338 P930029 008
00613994947345 P930029 008
00613994947352 P930029 008
00643169148147 P930029 010
00643169148161 P930029 010
00643169147805 P930029 010
00643169148123 P930029 010
00643169148109 P930029 010
00613994947277 P930029 012
00613994947284 P930029 012
00721902257575 P930029 013
00721902544903 P930029 013
00681490024105 P930029 013
00681490023900 P930029 013
00681490862028 P930029 013
00681490860765 P930029 013
00681490724364 P930029 013
00721902741890 P930029 013
00681490024273 P930029 013
00681490023863 P930029 013
00643169148086 P930029 014
00643169148048 P930029 014
00643169139428 P930029 015
00643169139411 P930029 015
00721902353864 P930029 018
00643169565920 P930029 018
00643169147966 P930029 021
00643169147904 P930029 021
00643169147942 P930029 021
00643169147928 P930029 021
00643169147980 P930029 021
00613994947291 P930029 044
00643169148062 P930029 044
00613994947307 P930029 044
00613994947253 P930029 044
00643169565913 P930029 048
00643169135642 P930029 048
00643169135604 P930029 048
00643169135581 P930029 048
00643169135567 P930029 048
00643169135598 P930029 049
00763000227692 P930029 065
00763000227685 P930029 065
00763000227678 P930029 065
00763000227661 P930029 065
00763000227654 P930029 065
00763000227647 P930029 065
00763000227630 P930029 065
00763000227708 P930029 065
00763000227715 P930029 065
00763000227722 P930029 065
00763000227814 P930029 065
00763000227838 P930029 065
00763000227739 P930029 065
00763000227746 P930029 065
00763000227753 P930029 065
00763000227760 P930029 065
00763000227777 P930029 065
00763000227623 P930029 065

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