MAF · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
MAF
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
N
Implant
Y
Third-party review
N
Definition
The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.