PMA P130008S035
- Device
- INSPIRE II UPPER AIRWAY STIMULATOR
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S035
- Product code
- MNQ
- Decision date
- 2018-09-14
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Alternate supplier of the pressure sensor component used in the Model 4323 Pressure Sensing Lead.
Current openFDA PMA Record#
- Device
- INSPIRE II UPPER AIRWAY STIMULATOR
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S035
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2018-09-14
- Decision code
- OK30
- Date received
- 2018-08-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier of the pressure sensor component used in the Model 4323 Pressure Sensing Lead.