INSPIRE II IMPLANTABLE PULSE GENERATOR
FDA premarket approval P130008/S015 · decided 2016-10-14
Approval details
- PMA number
- P130008
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSPIRE II IMPLANTABLE PULSE GENERATOR
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2016-09-14
- Decision date
- 2016-10-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Implement a change to the manufacturing procedure for annealing of the Model 3024 implantable pulse generator (IPG), which adds an in-house annealing process at 1st tier supplier Greatbatch Medical Minneapolis (GMM).
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