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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 NameSYMPHONY SR/DR & RHAPSODY SR/DR
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS039
Date Received11/13/2008
Decision Date02/04/2009
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the reply pacer embedded software w1. 5. 1 and associated programmer application software version smartview 2. 10 ug1.
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