Inspire Upper Airway Stimulation (UAS) System, Model 3028 IPG
FDA premarket approval P130008/S016 · decided 2017-05-05
Approval details
- PMA number
- P130008
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Inspire Upper Airway Stimulation (UAS) System, Model 3028 IPG
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2016-10-06
- Decision date
- 2017-05-05
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the Model 3028 MR Conditional Implantable Pulse Generator (IPG).
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