INSPIRE II IMPLANTABLE PULSE GENERATOR
FDA premarket approval P130008/S014 · decided 2016-08-03
Approval details
- PMA number
- P130008
- Supplement
- S014
- 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
- 2016-07-05
- Decision date
- 2016-08-03
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Implementation of additional peel strength testing for the Model 3024 Implantable Pulse Generator (IPG) at the contract manufacturer Medtronic MPROC Juncos Puerto Rico.
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