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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 NameDISCOVERY
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual-chamber adaptive-rate pacemaker
ApplicantGUIDANT CORP.
PMA NumberP940031
Supplement NumberS044
Date Received08/29/2005
Decision Date06/28/2006
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of inspection criteria to allow for solder balls under components on the hybrid.
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