MODEL 3024 INSPIRE II IMPLANTABLE PULSE GENERATOR (IPG)
FDA premarket approval P130008/S007 · decided 2015-04-22
Approval details
- PMA number
- P130008
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 3024 INSPIRE II IMPLANTABLE PULSE GENERATOR (IPG)
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2015-03-25
- Decision date
- 2015-04-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR INSPECTION OF FINAL SEALED TRAY PACKAGES AND A CHANGE IN THE SUPPLIER OF GOLD PREFORM COMPONENTS.
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