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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 NamePREMIER PACING SYSTEM
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namesingle chamber, sensor driven, implantable pulse
Applicant MEDTRONIC INC.
PMA NumberP850051
Supplement NumberS056
Date Received12/15/2000
Decision Date04/18/2001
Product Code
LWO
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the premier pacing system, including the premier model 8081 vvi pacemaker, the capsure model 4003m endocardial lead and the model 9884 software for the model 9790 and 9790c programmers.
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