Inspire Model 3028 Implantable Pulse Generator (IPG) and Model 4340 Inspire Sensing Lead
FDA premarket approval P130008/S097 · decided 2023-06-20
Approval details
- PMA number
- P130008
- Supplement
- S097
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Model 3028 Implantable Pulse Generator (IPG) and Model 4340 Inspire Sensing Lead
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2023-05-26
- Decision date
- 2023-06-20
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Change in manufacturing location for three injection-molded components of the device.
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