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U.S. Department of Health and Human Services

Product Classification

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Device implantable pulse generator, pacemaker (non-crt)
Definition These devices treat bradycardia (slow heartbeats) with ra and/or rv pacing therapy as necessary.
Physical State These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Technical Method These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Target Area These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Review Panel Cardiovascular
Product CodeLWP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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