Inspire IV IPG
FDA premarket approval P130008/S027 · decided 2017-11-08
Approval details
- PMA number
- P130008
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire IV IPG
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2017-10-13
- Decision date
- 2017-11-08
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Changes to update to software version 1.0.4 of the Serial Number Verification System for 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.