MPC · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.5300
Classification
FDA Product Code
MPC
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 870.5300
Review panel
CV
Medical specialty
Cardiovascular
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
Definition
Call for PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.