INSPIRE II UPPER AIRWAY STIMULATOR
FDA premarket approval P130008/S002 · decided 2015-02-05
Approval details
- PMA number
- P130008
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSPIRE II UPPER AIRWAY STIMULATOR
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2014-06-30
- Decision date
- 2015-02-05
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE TABLET HARDWARE AND OPERATING SYSTEM OF THE MODEL 2740 PHYSICIAN PROGRAMMER, AND RELATED CHANGES TO THE MODEL 2740 PROGRAMMER MANUAL.
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