PMA P130008S062
- Device
- Inspire IV IPG
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S062
- Product code
- MNQ
- Decision date
- 2020-10-14
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Changes to the insulation tape application process in the coil of the Model 2500 Patient Sleep Remote
Current openFDA PMA Record#
- Device
- Inspire IV IPG
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S062
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2020-10-14
- Decision code
- OK30
- Date received
- 2020-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the insulation tape application process in the coil of the Model 2500 Patient Sleep Remote