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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 NumberS026
Date Received06/13/2008
Decision Date07/09/2008
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate supplier for the torque wrench accessory used with icds, crt-ds, crt-ps, and pacemakers.
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