Inspire Model 2740 Physician Programmer
FDA premarket approval P130008/S034 · decided 2018-11-01
Approval details
- PMA number
- P130008
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Inspire Model 2740 Physician Programmer
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2018-04-16
- Decision date
- 2018-11-01
- Days to decision
- 199 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 software of the Model 2740 Physician Programmer.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.