PMA P130008S111
- Device
- Inspire Model 3028 Implantable Pulse Generator (IPG)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S111
- Product code
- MNQ
- Decision date
- 2024-05-30
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- changes to the frequency of Helium Leak Testing performed on the Right Hand Shield (RHS) of the Model 3028 IPG
Current openFDA PMA Record#
- Device
- Inspire Model 3028 Implantable Pulse Generator (IPG)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S111
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2024-05-30
- Decision code
- OK30
- Date received
- 2024-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the frequency of Helium Leak Testing performed on the Right Hand Shield (RHS) of the Model 3028 IPG