MODEL 2740 INSPIRE PROGRAMMER SYSTEM
FDA premarket approval P130008/S020 · decided 2017-08-02
Approval details
- PMA number
- P130008
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 2740 INSPIRE PROGRAMMER SYSTEM
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2017-01-23
- Decision date
- 2017-08-02
- Days to decision
- 191 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for an update to the telemetry head of the Model 2740 Programmer.
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