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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 NameVARIOUS FAMILIES/MODELS OF PASYS, SPECTRAX, SYMBIOS, & SYNERGYST
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP820003
Supplement NumberS113
Date Received09/22/2011
Decision Date11/17/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the operating system software for the carelink programmer associated with medtronic pacemaker, implantable cardioverter defibrillator (icd), and cardiac resynchronization therapy (crt) devices approved under the referenced pma.
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