IMPELLA 2.5 System
FDA premarket approval P140003 · Temporary non-roller type left heart support blood pump
Approval
- Applicant
- Abiomed, Inc.
- Received
- March 18, 2014
- Decision date
- March 23, 2015 (APPR)
- Supplements
- 127, latest June 15, 2026
- Product code
- OZD – Temporary Non-Roller Type Left Heart Support Blood Pump
Approval order statement
APPROVAL FOR THE IMPELLA. THIS DEVICE IS INDICATED FOR:THE IMPELLA 2.5 SYSTEM IS A TEMPORARY (<= 6 HOURS) VENTRICULAR SUPPORT DEVICE INDICATED FOR USE DURING HIGH RISK PERCUTANEOUS CORONARY INTERVENTIONS (PCI) PERFORMED IN ELECTIVE OR URGENT, HEMODYNAMICALLY STABLE PATIENTS WITH SEVERE CORONARY ARTERY DISEASE AND DEPRESSED LEFT VENTRICULAR EJECTION FRACTION, WHEN A HEART TEAM, INCLUDING A CARDIAC SURGEON, HAS DETERMINED HIGH RISK PCI IS THE APPROPRIATE THERAPEUTIC OPTION. USE OF THE IMPELLA 2.5 IN THESE PATIENTS MAY PREVENT HEMODYNAMIC INSTABILITY WHICH CAN RESULT FROM REPEAT EPISODES OF REVERSIBLE MYOCARDIAL ISCHEMIA THAT OCCUR DURING PLANNED TEMPORARY CORONARY OCCLUSIONS AND MAY REDUCE PERI- AND POST-PROCEDURAL ADVERSE EVENTS.