Temporary Non-Roller Type Left Heart Support Blood Pump
Basic Information
- Device Name
- Temporary Non-Roller Type Left Heart Support Blood Pump
- Trade Name
- IMPELLA 2.5 System
- PMA Number
- P140003
- Device Class
- FDA Class 3
- Product Code
- OZD
- Generic Name
- Temporary non-roller type left heart support blood pump
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 23, 2015
- Date Received
- March 18, 2014
- Expedited Review
- N
- Docket Number
- 25M-1177
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | FDA class 3 | Unknown |