Inspire Model 3028 Implantable Pulse Generator (IPG)
FDA premarket approval P130008/S106 · decided 2024-01-19
Approval details
- PMA number
- P130008
- Supplement
- S106
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Model 3028 Implantable Pulse Generator (IPG)
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2023-12-21
- Decision date
- 2024-01-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- approval to utilize laser welders IPG-003, IPG-004 and IPG-005 to perform hybrid welds in the manufacturing of the Inspire Model 3028 IPG
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