PMA P130008S021

Device

Inspire II Upper Airway Stimulator

Applicant

Inspire Medical Systems

PMA number

P130008

Supplement

S021

Product code

MNQ

Decision date

2017-06-23

Classification

Stimulator, Hypoglossal Nerve, Implanted, Apnea

Generic name

Stimulator, hypoglossal nerve, implanted, apnea

Approval order statement

Approval to expand the Apnea Hypopnea Index (AHI) range from 20 to 65, to 15 to 65 events per hour.

Summary

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