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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 NameMICRONY FAMILY OF PACEMAKERS
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Nameimplantable pacemaker pulse generator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP970013
Supplement NumberS038
Date Received11/23/2010
Decision Date04/04/2011
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for model 3330 version 12. 1 software for the model 3650 merlin patient care system.
Approval Order Approval Order
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