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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceIPULSE CIRCULATORY SUPPORT SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
ABIOMED CARDIOVASCULAR, INC.
22 cherry hill drive
danvers, MA 01923
PMA NumberP900023
Supplement NumberS051
Date Received04/07/2009
Decision Date06/05/2009
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increased field service interval of 5000 hours for the ipulse console.
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