PMA P130008S044
- Device
- Inspire II Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S044
- Product code
- MNQ
- Decision date
- 2019-06-21
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Manufacturing change to reduce vacuum bake time for the Model 3028 Implantable Pulse Generator prior to case seam welding.
Current openFDA PMA Record#
- Device
- Inspire II Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S044
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2019-06-21
- Decision code
- OK30
- Date received
- 2019-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to reduce vacuum bake time for the Model 3028 Implantable Pulse Generator prior to case seam welding.