Inspire Implantable Pulse Generator (IPG)
FDA premarket approval P130008/S077 · decided 2022-02-02
Approval details
- PMA number
- P130008
- Supplement
- S077
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Implantable Pulse Generator (IPG)
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2022-01-05
- Decision date
- 2022-02-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Notification of additional raw material suppliers.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.