Product code DSQ
- Device name
- Ventricular (Assist) Bypass
- 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
- Ineligible
- Definition
- Approved pma: P870072
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P100047S238 | Heart Ware™ Ventricular Assist System (HVAD) | Medtronic | 2026-05-14 |
| P170038S031 | CentriMag™ Circulatory Support System | Abbott | 2026-05-05 |
| P170038S030 | CentriMag™ Circulatory Support System | Abbott | 2026-05-04 |
| P170038S029 | CentriMag™ Circulatory Support System | Abbott | 2026-04-17 |
| P100047S223 | HEARTWARE VENTRICULAR ASSIST SYSTEM | Medtronic | 2026-04-10 |
| P100047S235 | HeartWare HVAD System | Medtronic | 2026-04-07 |
| P160054S124 | HeartMate 3™ Left Ventricular Assist System (LVAS) | ABBOTT MEDICAL | 2026-04-02 |
| P160054S123 | HeartMate 3™ Left Ventricular Assist System | ABBOTT MEDICAL | 2026-03-25 |
| P160054S120 | HeartMate 3™ Left Ventricular Assist System | ABBOTT MEDICAL | 2026-03-04 |
| P160054S119 | HeartMate 3™ Left Ventricular Assist System | ABBOTT MEDICAL | 2026-03-04 |
| P160054S114 | HeartMate 3™ Left Ventricular Assist System (LVAS) | ABBOTT MEDICAL | 2026-03-02 |
| P170038S028 | CentriMag Circulatory Support System | Abbott | 2026-02-18 |
| P160054S115 | HeartMate 3™ Left Ventricular Assist System (LVAS) | ABBOTT MEDICAL | 2026-02-18 |
| P100047S234 | HeartWare® HVAD System | Medtronic | 2026-02-18 |
| P060040S121 | HeartMate II Left Ventricular Assist System (LVAS) | ABBOTT MEDICAL | 2026-02-18 |
| P160054S118 | HeartMate 3™ Left Ventricular Assist System | ABBOTT MEDICAL | 2026-02-11 |
| P160054S117 | HeartMate 3 Left Ventricular Assist System | ABBOTT MEDICAL | 2026-02-04 |
| P170038S027 | CentriMag Circulatory Support System | Abbott | 2026-02-03 |
| P100047S236 | HeartWare® HVAD System | Medtronic | 2026-02-03 |
| P160035S055 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | 2025-12-19 |
| P160054S116 | HeartMate 3™ Left Ventricular Assist System | ABBOTT MEDICAL | 2025-12-17 |
| P060040S122 | HeartMate II™ Left Ventricular Assist System | ABBOTT MEDICAL | 2025-12-17 |
| P170038S025 | CentriMag™ Circulatory Support System | Abbott | 2025-12-01 |
| P160054S112 | HeartMate 3™ Left Ventricular Assist System (LVAS) | ABBOTT MEDICAL | 2025-11-04 |
| P160054S094 | HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System | ABBOTT MEDICAL | 2025-10-17 |
| P060040S112 | HeartMate Apical Coring Knife | ABBOTT MEDICAL | 2025-10-17 |
| P160054S113 | HeartMate 3 Left Ventricular Assist System | ABBOTT MEDICAL | 2025-10-09 |
| P160054S104 | HeartMate 3™ Left Ventricular Assist System | ABBOTT MEDICAL | 2025-10-06 |
| P170038S023 | CentriMag Circulatory Support System | Abbott | 2025-09-29 |
| P160035S049 | EXCOR Cannula Clip | Berlin Heart, Inc. | 2025-09-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000923655 | HeartWare™ Battery | Heartware, Inc. | 2026-05-01 |
| 07640135140153 | CentriMag™ | Thoratec Corporation | 2026-02-19 |
| 00763000989514 | HVAD™ Controller | Heartware Inc. | 2025-08-30 |
| 05415067039446 | HeartMate 3™ | Thoratec Corporation | 2025-07-21 |
| 05415067039545 | HeartMate™ | Thoratec Corporation | 2025-07-21 |
| 05415067039385 | HeartMate 3™ | Thoratec Corporation | 2025-07-21 |
| 05415067038784 | HeartMate 3™ | Thoratec Corporation | 2025-07-21 |
| 05415067039880 | HeartMate™ | Thoratec Corporation | 2025-07-21 |
| 05415067039903 | HeartMate™ GoGear™ | Thoratec Corporation | 2025-07-21 |
| 05415067039422 | HeartMate 3™ | Thoratec Corporation | 2025-07-16 |
| 05415067038173 | HeartMate™ GoGear™ | Thoratec Corporation | 2025-05-16 |
| 15415067037807 | HeartMate™ | Thoratec Corporation | 2025-05-16 |
| 05415067039927 | HeartMate™ GoGear™ | Thoratec Corporation | 2025-05-16 |
| 05415067039866 | HeartMate™ GoGear™ | Thoratec Corporation | 2025-05-16 |
| 05415067037824 | HeartMate™ | Thoratec Corporation | 2025-05-16 |
| 05415067039842 | HeartMate™ GoGear™ | Thoratec Corporation | 2025-05-16 |
| 05415067039781 | HeartMate™ GoGear™ | Thoratec Corporation | 2025-05-16 |
| 05415067039644 | HeartMate™ | Thoratec Corporation | 2025-05-16 |
| 05415067039606 | HeartMate™ | Thoratec Corporation | 2025-05-16 |
| 05415067038821 | HeartMate 3™ | Thoratec Corporation | 2025-05-16 |
| 05415067037800 | HeartMate™ | Thoratec Corporation | 2025-05-16 |
| 05415067038456 | HeartMate 3™ | Thoratec Corporation | 2025-04-07 |
| 05415067039323 | HeartMate 3™ | Thoratec Corporation | 2025-04-02 |
| 05415067038234 | HeartMate™ | Thoratec Corporation | 2024-03-22 |
| 05415067038432 | HeartMate 3™ | Thoratec Corporation | 2022-09-27 |
| 05415067038258 | HeartMate™ | Thoratec Corporation | 2022-09-27 |
| 05415067038272 | HeartMate™ | Thoratec Corporation | 2022-09-12 |
| 05415067039507 | HeartMate 3™ | Thoratec Corporation | 2022-06-14 |
| 05415067039484 | HeartMate 3™ | Thoratec Corporation | 2022-06-14 |
| 05415067039408 | HeartMate 3™ | Thoratec Corporation | 2022-06-14 |