• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nametemporary non-roller type cardiac support blood pump
ApplicantABIOMED, INC.
PMA NumberP140003
Date Received03/20/2014
Decision Date03/23/2015
Product Code
OZD[ Registered Establishments with OZD ]
Docket Number 25M-1177
Notice Date 04/10/2015
Advisory Committee Cardiovascular
Clinical Trials NCT00534859
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002