Physician Programmer Cable
FDA premarket approval P130008/S068 · decided 2021-08-31
Approval details
- PMA number
- P130008
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Physician Programmer Cable
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2021-05-28
- Decision date
- 2021-08-31
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the revision of Model 2740 Programmer cable firmware to v1.7.
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