Product code MAF
- Device name
- Stent, Coronary
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P160003S022 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2026-04-15 |
| P160003S026 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2026-04-01 |
| P130030 | REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE | Boston Scientific Corp | 2026-03-10 |
| P160003S025 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2025-07-10 |
| P160003S023 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2025-02-14 |
| P160003S021 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2024-05-17 |
| P160003S020 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2024-04-24 |
| P160003S019 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2024-03-26 |
| P130030S077 | REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire | Boston Scientific Corp | 2023-12-12 |
| P160003S018 | PRO-KINETIC ENERGY CORONARY STENT SYSTEM | Biotronik AG | 2023-08-16 |
| P160003S017 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2023-08-07 |
| P130030S076 | REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire | Boston Scientific Corp | 2023-07-27 |
| P020047S076 | MULTI-LINK VISION® RX Coronary Stent System, MULTI-LINK MINI VISION® RX Coronary Stent System | Abbott Vascular | 2023-06-14 |
| P020047S077 | MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK MINI VISION Coronary Stent System | Abbott Vascular | 2023-06-12 |
| P160003S016 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2023-03-03 |
| P130030S075 | REBEL Platinum Chromium Coronary Stent System | Boston Scientific Corp | 2023-03-02 |
| P130030S074 | REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire | Boston Scientific Corp | 2022-11-15 |
| P970020S086 | MULTI-LINK RX ULTRA™ Coronary Stent System | Abbott Vascular, Inc. | 2022-09-07 |
| P020047S075 | MULTI-LINK VISION™ RX Coronary Stent System, MULTI-LINK VISION™ RX 2.75 mm Coronary Stent System, MULTI-LINK MINI VISION | Abbott Vascular | 2022-09-07 |
| P160003S015 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2022-07-27 |
| P030009S101 | Integrity Coronary Stent Systems | Medtronic, Ireland | 2022-07-15 |
| P030009S107 | Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent System | Medtronic, Ireland | 2022-04-19 |
| P130030S073 | REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) | Boston Scientific Corp | 2022-02-25 |
| P030009S104 | Integrity Coronary Stent System | Medtronic, Ireland | 2022-01-27 |
| P030009S105 | Integrity Coronary Stent System RX and OTW | Medtronic, Ireland | 2021-12-14 |
| P030009S106 | Integrity Coronary Stent System Rx and OTW | Medtronic, Ireland | 2021-11-16 |
| P160014S018 | COBRA PzF NanoCoated Coronary Stent System | Celonova Biosciences, Inc. | 2021-10-12 |
| P160003S014 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG | 2021-07-13 |
| P970020S085 | Multi-Link RX Ultra Coronary Stent System | Abbott Vascular, Inc. | 2021-06-21 |
| P030009S103 | Integrity Coronary Stent System Rx and OTW | Medtronic, Ireland | 2021-05-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20705032057346 | PALMAZ Balloon Expandable Stent | CORDIS CORPORATION | 2015-05-07 |
| 20705032057247 | PALMAZ Balloon Expandable Stent | CORDIS CORPORATION | 2015-05-07 |
| 20705032057261 | PALMAZ Balloon Expandable Stent | CORDIS CORPORATION | 2015-05-07 |
| 20705032057285 | PALMAZ Balloon Expandable Stent | CORDIS CORPORATION | 2015-05-07 |
| 10705032076241 | PALMAZ Balloon Expandable Stent | Cordis US Corp. | 2015-05-07 |
| 10705032076234 | PALMAZ Balloon Expandable Stent | Cordis US Corp. | 2015-05-07 |
| 10705032076197 | PALMAZ Balloon Expandable Stent | Cordis US Corp. | 2015-05-07 |
| 10705032064736 | PALMAZ Balloon Expandable Stent | Cordis US Corp. | 2015-05-07 |
| 20705032057223 | PALMAZ Balloon Expandable Stent | CORDIS CORPORATION | 2015-04-29 |
| 10705032076227 | PALMAZ Balloon Expandable Stent | Cordis US Corp. | 2015-04-29 |
| 08714729406471 | WALLSTENT™ RP Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-03-24 |
| 08714729203940 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-03-24 |
| 08714729203957 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-03-24 |
| 08717648176449 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176340 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176357 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176364 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176395 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176401 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176418 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176487 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176456 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176463 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176470 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176524 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176517 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176500 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176494 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 20705032057315 | PALMAZ Balloon Expandable Stent | CORDIS CORPORATION | 2014-09-19 |
| 10705032057318 | PALMAZ Balloon Expandable Stent | Cordis US Corp. | 2014-09-19 |