Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
NKE · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NKE
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
CV
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
Definition
These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.