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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 NameSYNERGYST II PULSE GENERATOR
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS071
Date Received08/19/2003
Decision Date09/17/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 2490d/e carelink monitors and model 2491 ddma software to allow their use with the insync icd model 7272 & insync marquis model 7277. The carelink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.
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