INSPIRE UPPER AIRWAY STIMULATION THERAPY
FDA premarket approval P130008/S008 · decided 2015-08-24
Approval details
- PMA number
- P130008
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INSPIRE UPPER AIRWAY STIMULATION THERAPY
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2015-05-27
- Decision date
- 2015-08-24
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE MODEL 3024 IMPLANTABLE PULSE GENERATOR (IPG) TO 3 YEARS.
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