Inspire Stimulation and Sensing Leads
FDA premarket approval P130008/S050 · decided 2020-03-30
Approval details
- PMA number
- P130008
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Stimulation and Sensing Leads
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2020-01-06
- Decision date
- 2020-03-30
- Days to decision
- 84 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- to update design documents of Model 4063 stimulation lead and Model 4340 sensing lead to clarify manufacturing instructions for silicone adhesive backfill requirements
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.