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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device leadless cardiac resynchronization therapy (crt)
Definition Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant
Product CodeSEG
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 0 0 2

MDR Year MDR Reports MDR Events
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 5 5
Activation, Positioning or Separation Problem 1 1
Communication or Transmission Problem 1 1
Battery Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Heart Problem 7 7
No Clinical Signs, Symptoms or Conditions 1 1

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