Myocardial Pacing Lead

FDA Premarket Approval P120017 S028

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

For minor modifications, including new ovens and a new toolmaker's scope at medtronic rice creek.

DeviceMyocardial Pacing Lead
Generic NamePermanent Pacemaker Electrode
ApplicantMEDTRONIC Inc.
Date Received2021-08-09
Decision Date2021-08-17
PMAP120017
SupplementS028
Product CodeDTB 
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
P120017Original Filing
S028 2021-08-09 30-day Notice
S027 2021-02-05 30-day Notice
S026 2020-12-01 30-day Notice
S025 2020-11-24 30-day Notice
S024 2020-10-23 30-day Notice
S023 2020-07-09 30-day Notice
S022 2020-06-26 30-day Notice
S021 2020-03-23 Real-time Process
S020 2019-11-18 30-day Notice
S019 2019-09-16 30-day Notice
S018 2019-06-10 30-day Notice
S017 2019-02-28 30-day Notice
S016 2018-10-23 30-day Notice
S015 2018-10-18 30-day Notice
S014 2018-09-26 30-day Notice
S013 2018-05-15 30-day Notice
S012 2018-02-22 30-day Notice
S011 2017-11-20 30-day Notice
S010 2017-08-07 30-day Notice
S009 2017-06-28 30-day Notice
S008 2017-06-07 30-day Notice
S007 2016-11-14 30-day Notice
S006 2016-10-05 30-day Notice
S005 2016-08-25 30-day Notice
S004 2016-06-24 30-day Notice
S003 2015-12-28 30-day Notice
S002 2015-12-22 30-day Notice
S001 2015-09-10 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169638624 P120017 000
00643169638617 P120017 000
00643169638600 P120017 000
00643169638594 P120017 000

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