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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.
 
DeviceVENTAK PRIZM DR/VR AICD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP960040
Supplement NumberS012
Date Received08/23/1999
Decision Date01/21/2000
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval is for modifications to VENTAK DR/VR AICD. The device, as modified, will be marketed under the tradename VENTAK PRIZM DR/VR AICD System, Models 1850, 1851, 1855 and 1856 with Model 2844 Software, Version 1.1 and the indications remains the same as in the original PMA.
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