PMA P130008S036

Device

Inspire Model 4323 Sensing Lead

Applicant

Inspire Medical Systems

PMA number

P130008

Supplement

S036

Product code

MNQ

Decision date

2018-11-19

Classification

Stimulator, Hypoglossal Nerve, Implanted, Apnea

Generic name

Stimulator, hypoglossal nerve, implanted, apnea

Approval order statement

Additional laser welder for use in the production of the pressure sensor used in the Model 4323 lead.

Summary

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