Inspire Implantable Pulse Generator (IPG)
FDA premarket approval P130008/S088 · decided 2022-08-19
Approval details
- PMA number
- P130008
- Supplement
- S088
- 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
- 2022-07-29
- Decision date
- 2022-08-19
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Additional qualified supplier for barium titanate.
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