Inspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead
FDA premarket approval P130008/S084 · decided 2022-06-16
Approval details
- PMA number
- P130008
- Supplement
- S084
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2022-05-20
- Decision date
- 2022-06-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Notification of replacing obsolete Metal- Oxide- Semiconductor Field-Effect Transistor (MOSFET) for the Sensor Assembly and additional lathe equipment to be used to manufacture the terminal pin used in the connector assembly of the leads for the Inspire Models 4340 and 4063 Respiratory Sensing Leads
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.