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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, collagen, diaphragmatic hernia
Definition For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.
Product CodeOWV
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 1 1
Patient Device Interaction Problem 1 1

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

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