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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.
 
DeviceTHORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC LABORATORIES CORP.
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS024
Date Received12/11/2002
Decision Date12/31/2002
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a warning statement to the package labels and to the instructions for use for the beveled-tip atrial cannula, as used with the thoratec ventricular assist device (vad) system.
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