PMA P130008S045
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S045
- Product code
- MNQ
- Decision date
- 2019-07-25
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Reduce the energy used in the seam welding process of the sensor component of the Model 4340 and Model 4323 Sensor Lead at the contract manufacturer Cirtec Medical.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S045
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2019-07-25
- Decision code
- OK30
- Date received
- 2019-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce the energy used in the seam welding process of the sensor component of the Model 4340 and Model 4323 Sensor Lead at the contract manufacturer Cirtec Medical.