INSPIRE II UPPER AIRWAY STIMULATOR
FDA premarket approval P130008 · decided 2014-04-30
Approval details
- PMA number
- P130008
- Trade name
- INSPIRE II UPPER AIRWAY STIMULATOR
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2013-05-01
- Decision date
- 2014-04-30
- Days to decision
- 364 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE INSPIRE UPPER AIRWAY STIMULATION (UAS) SYSTEM, WHICH INCLUDES THE MODEL 3024 IMPLANTABLE PULSE GENERATOR, THE MODEL 4063 STIMULATION LEAD, THE MODEL 4323 SENSING LEAD, THE MODEL 2740PHYSICIAN PROGRAMMER, AND THE MODEL 3032 PATIENT PROGRAMMER. THE DEVICE IS USED TO TREAT A SUBSET OF PATIENTS WITH MODERATE TO SEVERE OBSTRUCTIVE SLEEP APNEA (OSA) (APNEA-HYPOPNEA INDEX [AHI] OF GREATER OR EQUAL TO 20 AND LESS THAN OR EQUAL TO 65). INSPIRE UAS IS USED IN ADULT PATIENTS 22 YEARS OF AG
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