• 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
 
Trade NameIMPELLA
ApplicantABIOMED, INC.
PMA NumberP140003
Date Received03/20/2014
Decision Date03/23/2015
Product Code
OZD
Advisory Committee Cardiovascular
Clinical Trials NCT00534859
NCT00562016
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
-
-