Pressure Sensor Test Limits
FDA premarket approval P130008/S032 · decided 2018-03-07
Approval details
- PMA number
- P130008
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pressure Sensor Test Limits
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2018-02-05
- Decision date
- 2018-03-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Changes to update the Model 4323 lead gain and frequency response limits in the test specification.
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