Inspire Model 4340 Respiratory Sensing Lead
FDA premarket approval P130008/S081 · decided 2022-03-14
Approval details
- PMA number
- P130008
- Supplement
- S081
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Model 4340 Respiratory Sensing Lead
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2022-02-17
- Decision date
- 2022-03-14
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Notification of replacing obsolete Metal- Oxide- Semiconductor Field-Effect Transistor (MOSFET) for the Sensor Assembly in the Inspire Model 4340 Respiratory Sensing Lead.
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