Myocardial Pacing Lead

FDA Premarket Approval P120017 S021

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 a change to the lead serial number ink/foil material for select implantable leads.

DeviceMyocardial Pacing Lead
Generic NamePermanent Pacemaker Electrode
ApplicantMEDTRONIC Inc.
Date Received2020-03-23
Decision Date2020-06-02
PMAP120017
SupplementS021
Product CodeDTB 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
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
00643169638624 P120017 000
00643169638617 P120017 000
00643169638600 P120017 000
00643169638594 P120017 000

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