Model 3028 Implantable Pulse Generator
FDA premarket approval P130008/S037 · decided 2019-01-24
Approval details
- PMA number
- P130008
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Model 3028 Implantable Pulse Generator
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2018-10-26
- Decision date
- 2019-01-24
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a new potting epoxy within the Model 3028 IPG.
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