Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications [PMA Approval; 30-day use]: Temporary circulatory support for up to 30 days for one or both sides of the heart to treat post-cardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient’s heart will recover or whether the patient will need alternative, longer-term therapy.
Contraindications [PMA Approval; 30-day use]: The CentriMag™ Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Adverse Events [PMA Approval; 30-day use]: Adverse events that may be associated with mechanical circulatory support can include, but are not limited to, the following: bleeding on device support, hemolysis, infection, renal failure/dysfunction/complication, respiratory dysfunction, hepatic dysfunction, cardiac arrhythmias (atrial or ventricular), thromboembolism (venous and arterial non-CNS), hypotension, hypertension, device malfunction or failure, psychiatric events, right heart failure, and death.
Indications [Humanitarian Exemption Device (HDE) Approval; 30-day use]: The CentriMag Circulatory Support System is intended to provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure.
Contraindications [Humanitarian Exemption Device (HDE) Approval; 30-day use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Humanitarian Device Statement: Caution: Humanitarian Device. The CentriMag Circulatory Support System is authorized by Federal Law for temporary circulatory support for up to 30 days for patients in cardiogenic shock due to right ventricular failure. The effectiveness of this device for this use has not been demonstrated.
Temporary Expanded Indication: A.M.G. MODULE PMP NO T.P. STERILE is indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure during the COVID-19 public health emergency.
Indications [510(k) Clearance; 6-hour use]: The AMG MODULE PMP NO T.P. STERILE is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The AMG MODULE PMP NO T.P. STERILE is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. Contact with blood for a longer period of time is unadvisable. AMG MODULE PMP NO T.P. STERILE is an adult oxygenator. The AMG MODULE PMP NO T.P. STERILE should be used in combination with medical devices listed in section “Medical devices for use with the AMG MODULE PMP NO T.P. STERILE.”
Contraindications [510(k) Clearance; 6-hour use]: This device used for any other purposes than for the indicated intended use is the responsibility of the user. See Instructions for Use.
Temporary Expanded Indication: A.M.G. PMP PEDIATRIC is indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure.
Indications [510(k) Clearance; 6-hour use]: The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for 6 hours or less with a maximum blood flow rate of 4 liters/minute.
Contraindications [510(k) Clearance; 6-hour use]: No contraindications are known if the device is used for the purpose described and in accordance with the stated operating conditions. Do not use the device for any purpose other than indicated.
Temporary Expanded Indication: A.M.G. PMP INFANT is indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure.
Indications [510(k) Clearance; 6-hour use]: The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for 6 hours or less with a maximum blood flow rate of 1.5 liters/minute.
Contraindications [510(k) Clearance; 6-hour use]: No contraindications are known if the device is used for the purpose described and in accordance with the stated operating conditions. Do not use the device for any purpose other than indicated.
Temporary Expanded Indication: A.M.G. MODULE PP NO T.P. STERILE is indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure during the COVID-19 public health emergency.
Indications [510(k) Clearance; 6-hour use]: The A.M.G. MODULE PP NO T.P. STERILE is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The A.M.G. MODULE PP NO T.P. STERILE is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. Contact with blood for a longer period of time is unadvisable. A.M.G. MODULE PP NO T.P. STERILE is an adult oxygenator. The A.M.G. MODULE PP NO T.P. STERILE should be used in combination with medical devices listed in section "Medical devices for use with the A.M.G. MODULE PP NO T.P. STERILE".
Contraindications [510(k) Clearance; 6-hour use]: Do not use the device for any purpose other than indicated. This device used for any other purposes than for the indicated intended use is the responsibility of the user. Relative contraindications to CPB procedures applies.
Temporary Expanded Indication: The FDA issued an enforcement policy guidance document in April 2020 allowing for FDA-cleared or approved cardiopulmonary bypass devices to be used in an ECMO circuit to treat patients who are experiencing acute respiratory failure and/or acute cardiopulmonary failure during the COVID-19 public health emergency. The CentriMag™ System including the CentriMag™ Blood Pump and PediMag™ Blood Pump are indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure.
Indications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).
Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Indications for Use [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is indicated for use with the CentriMag Circulatory Support System console and motor to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).
Contraindications [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is contraindicated for use as a cardiotomy suction device. The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Indications for Use [510(k) Clearance; 6-hour use]: The CentriMag™ Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative. The CentriMag Drainage (Venous) Cannula is not intended for peripheral cannulation.
Indications for Use [510(k) Clearance; 6-hour use]: The CentriMag™ Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative. The CentriMag Return (Arterial) Cannula is not intended for peripheral cannulation.
MAT-2006915 v4.0
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.
CardioMEMS™ HF System Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.
CardioMEMS™ HF System Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolization, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.
myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgement that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
HeartMate 3™ LVAS Indications: The HeartMate 3™ Left Ventricular Assist System is indicated for providing short and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.
HeartMate II™ LVAS Indications: The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.
HeartMate 3™ and HeartMate II™ LVAS Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.
HeartMate 3™ and HeartMate II™ LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System are listed below: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS), thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and possible pump thrombosis.
MAT-2207924 v1.0
MAT-2100151 v1.0
