Model 4063 Stimulation Lead and 4340 Sensing Lead
FDA premarket approval P130008/S109 · decided 2024-04-24
Approval details
- PMA number
- P130008
- Supplement
- S109
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Model 4063 Stimulation Lead and 4340 Sensing Lead
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2024-03-28
- Decision date
- 2024-04-24
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- A change to the IS-1 connector manufacturing process of the Model 4063 Stimulation Lead and 4340 Sensing Lead to introduce a two-cavity mold and to change the method used to inspect IS-1 Critical To Quality (CTQ) dimensions.
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