Inspire Model 3028 Implantable Pulse Generator (IPG)
FDA premarket approval P130008/S107 · decided 2024-03-13
Approval details
- PMA number
- P130008
- Supplement
- S107
- 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
- 2024-02-13
- Decision date
- 2024-03-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- The change associated with this submission is to remove the time-bounded 72 hours testing window between burn in and functional test. If the units exceed 96 hours (24 hours cool down + 72 hours in scope of this submission) after burn-in, the units need to complete an additional 24-hour burn-in and 24-hour cooldown prior to functional test.
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