SDL · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SDL
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
AN
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older.