PMA P130008S059
- Device
- Inspire Upper Airway Stimulation
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S059
- Product code
- MNQ
- Decision date
- 2020-09-24
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Implementation of a new capillary tool for wire bonding process for the membrane subassembly used in Model 4340 sensing lead.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S059
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2020-09-24
- Decision code
- OK30
- Date received
- 2020-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new capillary tool for wire bonding process for the membrane subassembly used in Model 4340 sensing lead.