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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.
 
Trade NameTHORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP920014
Supplement NumberS023
Date Received01/14/2004
Decision Date07/08/2004
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the powersonic sealed lead acid battery (model ps-1223) as a replacement for the no longer manufactured panasonic sealed lead acid battery (model lc-sa122r3eu) as a source of battery power to drive the heartmate ve and zve left ventricular assist systems.
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