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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiac device identifier
Definition A cardiac device identifier is a noninvasive device that is intended to provide information about implanted cardiac devices. The device detects and matches telemetry based on manufacturer-specific wireless communication signals, including radiofrequency or inductive signals, to identify an implanted cardiac device, including manufacturer, model, or type. The device is not intended to deliver therapeutic stimulation to, modify the programming of, or manipulate the stored data of the implanted device.
Product CodeSJJ
Regulation Number 870.3645
Device Class 2


Premarket Reviews
ManufacturerDecision
BRIDGESOURCE MEDICAL CORPORATION
  GRANTED 1

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