PMA P130008S078
- Device
- Inspire Implantable Pulse Generator (IPG) Model 2580 Patient Remote
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S078
- Product code
- MNQ
- Decision date
- 2022-02-11
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Notification of introducing a multi-cavity mold to manufacture Model 2580 patient remote buttons.
Current openFDA PMA Record#
- Device
- Inspire Implantable Pulse Generator (IPG) Model 2580 Patient Remote
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S078
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2022-02-11
- Decision code
- OK30
- Date received
- 2022-01-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Notification of introducing a multi-cavity mold to manufacture Model 2580 patient remote buttons.