Silicone Stimulation Lead, Silicone Sensing Lead
FDA premarket approval P130008/S074 · decided 2022-04-29
Approval details
- PMA number
- P130008
- Supplement
- S074
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Silicone Stimulation Lead, Silicone Sensing Lead
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2021-08-30
- Decision date
- 2022-04-29
- Days to decision
- 242 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the Model 4063 Silicone Stimulation Lead and the Model 4340 Silicone Sensing Lead lengths 25cm and 45cm.
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