Inspire Programmer System
FDA premarket approval P130008/S056 · decided 2021-02-12
Approval details
- PMA number
- P130008
- Supplement
- S056
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Inspire Programmer System
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2020-07-31
- Decision date
- 2021-02-12
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for:1) Updated version of the Model 2740 Inspire Programmer System;2) Minor software changes to the Application Module (AM)/Tablet;3) Manufacturing process changes to reduce scrap for the new programmer cable;4) Changes to improve aesthetics of the programmer cable; and5) Minor software updates regarding non-English languages for the European market and minor bug fixes.
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