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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 NameSENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable cardiac pacemaker pulse generator
ApplicantST. JUDE MEDICAL
PMA NumberP880006
Supplement NumberS052
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 - software
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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