Inspire Respiratory Sensing Lead and Inspire Stimulation Lead
FDA premarket approval P130008/S083 · decided 2022-04-07
Approval details
- PMA number
- P130008
- Supplement
- S083
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Respiratory Sensing Lead and Inspire Stimulation Lead
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2022-03-15
- Decision date
- 2022-04-07
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Additional lathe equipment to be used to manufacture the terminal pin used in the connector assembly of the Inspire leads, Model 4340 and Model 4063, to increase production capacity.
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