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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulse generator, permanent, implantable
Definition Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Product CodeNVZ
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
122 88 76 61 59 60 73 40 44 39 22

MDR Year MDR Reports MDR Events
2014 3107 3107
2015 2773 2773
2016 2554 2554
2017 3164 3164
2018 5877 5877
2019 8186 8186
2020 8337 8337
2021 8537 8537
2022 7791 7791
2023 8466 8466
2024 4394 4394

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Sep-13-2024
2 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-19-2018
3 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jul-05-2016
4 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-04-2016
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Dec-16-2021
6 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2020
7 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-14-2019
8 St Jude Medical Cardiac Rhythm Management Division II Sep-28-2015
9 St Jude Medical Cardiac Rhythm Management Division II Jan-09-2015
10 St Jude Medical, Cardiac Rhythm Management Division II Feb-24-2020
11 St. Jude Medical, Cardian Rhythm Management Division I May-07-2021
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