MAF — Stent, Coronary Class III

FDA Device Classification

FDA product code MAF covers "Stent, Coronary", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
MAF
Device Class
Class III
Regulation Number
Submission Type
Review Panel
CV
Medical Specialty
Unknown
Implant
Yes

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.