Inspire Model 4340 Respiratory Sensing Lead
FDA premarket approval P130008/S075 · decided 2021-11-03
Approval details
- PMA number
- P130008
- Supplement
- S075
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Model 4340 Respiratory Sensing Lead
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2021-10-07
- Decision date
- 2021-11-03
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Additional weld equipment, inspections and rework steps in the manufacturing of the Inspire model 4340 Respiratory Sensing Lead.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.