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 VENTRICULAR SUPPORT SYSTEMS
- PMA Number
- P140003
- Supplement Number
- S004
- 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
- April 7, 2016
- Date Received
- August 12, 2015
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 16M-1915
Advisory Committee Statement
Approval for the Impella 2.5, Impella CP, Impella 5.0, and Impella LD catheters, in conjunction with the Automated Impella Controller, are temporary ventricular support devices intended for short term use (<= 4 days for the Impella 2.5 and Impella CP, and <=6 days for the Impella 5.0 and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.* The intent of the Impella System therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.*Optimal medical management and conventional measures include volume loading, use of pressors and inotropes support with or without IABP.
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 |