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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 II SR MODEL 2525T/MICRONY K SR MODEL 2535K PULSE GENERATORS
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Nameimplantable pacemaker pulse generator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP970013
Supplement NumberS001
Date Received03/13/2001
Decision Date04/30/2001
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for microny ii sr+ model 2525t and microny k sr model 2535k pulse generators.
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