MAF · Stent, Coronary
· Class 3
Overview
| Product Code | MAF |
|---|---|
| Device Name | Stent, Coronary |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
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.
Cleared Devices (21)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P130030 | REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE | Boston Scientific Corp | Mar 10, 2026 | APPR |
| P160014 | COBRA PzF NanoCoated Coronary Stent System | Celonova Biosciences, Inc. | Feb 21, 2017 | APWD |
| P150039 | TRYTON SIDE BRANCH STENT | Poseidon Medical, Inc. | Feb 21, 2017 | APPR |
| P160003 | PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM | Biotronik, Inc. | Feb 14, 2017 | APPR |
| P110004 | PRESILLION PLUS COCR CORONARY STENT RX SYSTEM | Medinol, Ltd. | Apr 12, 2012 | APWD |
| P030037 | RITHRON-XR CORONARY STENT SYSTEM | Biotronik GmbH & Co. KG | Apr 29, 2005 | APWD |
| P040016 | VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM | Boston Scientific Scimed, Inc. | Apr 12, 2005 | APWD |
| P020040 | NIRFLEX PREMOUNTED STENT | Medinol, Ltd. | Oct 24, 2003 | APWD |
| P030009 | DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS | Medtronic, Ireland | Oct 1, 2003 | APWD |
| P020047 | MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS | Abbott Vascular | Jul 16, 2003 | APPR |
| P020009 | EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS | Boston Scientific Scimed, Inc. | Sep 11, 2002 | APWD |
| P000022 | BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM | Medtronic Vascular | Oct 16, 2000 | APWD |
| P000011 | BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM | Abbott Vascular, Inc. | Sep 29, 2000 | APWD |
| P980009 | MAGIC WALLSTENT ENDOPROTHESIS | Boston Scientific Scimed, Inc. | Sep 29, 1998 | APWD |
| P980001 | NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM | Boston Scientific Corp | Aug 11, 1998 | APWD |
| P970061 | SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM | Boston Scientific Scimed, Inc. | Jul 16, 1998 | APWD |
| P970035 | AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM | Medtronic, Ireland | Dec 23, 1997 | APWD |
| P970020 | MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS | Abbott Vascular, Inc. | Oct 2, 1997 | APWD |
| P960010 | MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM | Medtronics Interventional Vascular | Jun 27, 1997 | APWD |
| P900043 | PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT | Cordis Corp. | Aug 2, 1994 | APWD |
| P910030 | GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) | Cook, Inc. | Feb 8, 1993 | APWD |
Top Applicants
- Boston Scientific Scimed, Inc. — 4 clearances
- Medtronic, Ireland — 2 clearances
- Medinol, Ltd. — 2 clearances
- Boston Scientific Corp — 2 clearances
- Abbott Vascular, Inc. — 2 clearances
