Inspire Model 3028 Implantable Pulse Generator (IPG)
FDA premarket approval P130008/S111 · decided 2024-05-30
Approval details
- PMA number
- P130008
- Supplement
- S111
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Model 3028 Implantable Pulse Generator (IPG)
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2024-05-01
- Decision date
- 2024-05-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- changes to the frequency of Helium Leak Testing performed on the Right Hand Shield (RHS) of the Model 3028 IPG
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.