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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous (valvuloplasty)
Product CodeMAD
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 0 0 2 0 0

MDR Year MDR Reports MDR Events
2021 1 1
2022 4 4
2023 2 2
2024 2 2
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Mitral Valve Insufficiency/ Regurgitation 10 10
Tissue Breakdown 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Mitral Perforation 1 1

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