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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 NameVENTAK FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Name pulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS051
Date Received06/24/2005
Decision Date07/22/2005
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate supplier of the trim resistor arrays used in the hybrid builds of the pulsar max, ventak and contak cd families of devices.
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