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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, carotid sinus nerve
Regulation Description Carotid sinus nerve stimulator.
Definition Call for pmas 12/26/96 (61 fr 50706 (9/27/96)).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDSR
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type PMA
Regulation Number 870.3850
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible