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U.S. Department of Health and Human Services

Product Classification

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Device leadless pacemaker
Regulation Description Implantable pacemaker pulse generator.
Definition To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Physical State TBD
Technical Method TBD
Target Area TBD
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePNJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type PMA
Regulation Number 870.3610
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible