Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
The Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator is an implantable neurostimulator device intended for patients with stable, high spinal cord injuries who have stimulatable diaphragms but lack voluntary diaphragmatic control, enabling them to breathe without mechanical ventilator assistance for at least four continuous hours per day; it is indicated for adults 18 years and older. Classified as FDA Class 3 requiring Premarket Approval (PMA), it is both an implant and a life-sustaining/life-supporting device given its role in maintaining independent respiration; it is reviewed by the Anesthesiology panel. The product code is OIR; no regulation number has been assigned. Both the implant flag and the life-sustaining/support flag are active.
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Basic Information
- Product Code
- OIR
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- AN
- Submission Type
- 2
Device Characteristics
Definition
The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.