MODEL 3150 IMPLANTABLE PULSE GENERATOR (IPG)
FDA premarket approval P130008/S127 · decided 2025-07-21
Approval details
- PMA number
- P130008
- Supplement
- S127
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 3150 IMPLANTABLE PULSE GENERATOR (IPG)
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2025-06-24
- Decision date
- 2025-07-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- manufacturing change to the Theta 1 ASIC component of the 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.