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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device implanted diaphragmatic/phrenic nerve stimulator
Definition Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
Product CodeGZE
Regulation Number 882.5830
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 0 0 0 0 0

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Inappropriate/Inadequate Shock/Stimulation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Pain 1 1
Pain 1 1

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