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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.
 
DevicePARAGON/PHOENIX FAMILY OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP830045
Supplement NumberS109
Date Received04/23/2007
Decision Date05/09/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3330 version6. 1. 1 software for the model 3650 merlin patient care system and model 3307 version 6. 4. 1 software for the model 3510 programmer which enables v-v timing, af suppression and quickopt timing cycle optimization in the frontier ii model 5586 crt-p device. The device, as modified, will be marketed under the trade names as specified in the device families and is indicated for rate adaptive pacing, cardioversion and defibrillation and/or treatment of heart failure with cardiac resynchronization therapy.
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