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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 NameDUAL CHAMBER, IMPLANTABLE PULSE GENERATOR
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP820003
Supplement NumberS089
Date Received02/06/2009
Decision Date03/06/2009
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transferring the final in-process inspection and final packaging process steps for the model 5409 pouch-disposable, 5pk to the contract manufacturer¿s facility in medina, minnesota.
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