Inspire II Upper Airway Stimulator
FDA premarket approval P130008/S044 · decided 2019-06-21
Approval details
- PMA number
- P130008
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire II Upper Airway Stimulator
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2019-05-23
- Decision date
- 2019-06-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Manufacturing change to reduce vacuum bake time for the Model 3028 Implantable Pulse Generator prior to case seam welding.
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