Product code MOM
- Device name
- System, Hemodynamic, Implantable
- 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
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P100045S089 | CardioMEMS™ HF System | ABBOTT MEDICAL | 2026-05-13 |
| P100045S088 | CardioMEMS™ HF System | ABBOTT MEDICAL | 2026-03-25 |
| P230040S029 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2026-03-02 |
| P100045S086 | Next Gen Patient System – CM1200 CardioMEMS HERO Device | ABBOTT MEDICAL | 2026-02-27 |
| P230040S028 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2026-02-24 |
| P230040S027 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2026-02-17 |
| P230040S026 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2026-02-13 |
| P230040S025 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2026-01-09 |
| P100045S082 | CardioMEMS™ HF System | ABBOTT MEDICAL | 2026-01-09 |
| P230040S015 | CorPASS System | Endotronix, Inc. | 2025-12-19 |
| P230040S024 | CorPASS System | Endotronix, Inc. | 2025-11-25 |
| P100045S087 | CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) | ABBOTT MEDICAL | 2025-11-10 |
| P230040S023 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-10-22 |
| P230040S022 | CorPASS System | Endotronix, Inc. | 2025-10-06 |
| P230040S020 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-09-30 |
| P230040S021 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-09-29 |
| P100045S079 | CardioMEMS HF System | ABBOTT MEDICAL | 2025-09-24 |
| P100045S085 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM | ABBOTT MEDICAL | 2025-09-17 |
| P230040S019 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-09-10 |
| P100045S084 | CardioMEMSTM HF System | ABBOTT MEDICAL | 2025-09-10 |
| P230040S018 | CorPASS System | Endotronix, Inc. | 2025-08-26 |
| P230040S017 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-08-14 |
| P100045S083 | CardioMEMS HF System | ABBOTT MEDICAL | 2025-07-28 |
| P230040S011 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-06-25 |
| P230040S012 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-06-20 |
| P230040S016 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-06-12 |
| P100045S081 | CardioMEMS HF System | ABBOTT MEDICAL | 2025-05-15 |
| P230040S014 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-05-13 |
| P230040S013 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | 2025-05-13 |
| P100045S077 | CardioMEMS HF System | ABBOTT MEDICAL | 2025-02-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05415067047014 | CardioMEMS™ | CARDIOMEMS, INC. | 2026-03-13 |
| 05415067047021 | CardioMEMS™ | CARDIOMEMS, INC. | 2026-03-13 |
| 05415067047038 | CardioMEMS™ | CARDIOMEMS, INC. | 2026-03-13 |
| 05415067047045 | CardioMEMS™ | CARDIOMEMS, INC. | 2026-03-13 |
| 05415067048325 | CardioMEMS™ | CARDIOMEMS, INC. | 2026-03-13 |
| 05415067049612 | CardioMEMS™ | CARDIOMEMS, INC. | 2026-03-13 |
| 05415067054838 | CardioMEMS™ | CARDIOMEMS, INC. | 2026-03-13 |
| 00850008997143 | myCordella Handheld Patient Reader Alloy | Endotronix, Inc. | 2025-10-13 |
| 00850008997006 | Cordella Sensor Delivery Kit | Endotronix, Inc. | 2024-08-14 |
| 00850008997020 | Cordella Calibration Equipment | Endotronix, Inc. | 2024-08-13 |
| 00850008997051 | Cordella Data Analysis Platform | Endotronix, Inc. | 2024-08-13 |
| 00850008997013 | myCordella Handheld Patient Reader | Endotronix, Inc. | 2024-08-13 |
| 05414734509206 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-22 |
| 05414734509220 | CardioMEMS™ | CARDIOMEMS, INC. | 2023-06-22 |
| 05414734509268 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-22 |
| 05414734510257 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509978 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509923 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509916 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509909 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509398 | CardioMEMS™ | CARDIOMEMS, INC. | 2023-06-21 |
| 05414734509312 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509299 | CardioMEMS™ | CARDIOMEMS, INC. | 2023-06-21 |
| 05414734509282 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509275 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509251 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509213 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509190 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734509183 | CardioMEMS™ | ST. JUDE MEDICAL, INC. | 2023-06-21 |
| 05414734510035 | Merlin.net | CARDIOMEMS, INC. | 2016-05-02 |