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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 DR/SR & ELA RHAPSODY +DR/DR/SR
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS037
Date Received06/23/2008
Decision Date07/23/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing process changes enhancing the quality controls pertaining to symphony and rhapsody pacemakers as well as ovatio icd and crt-d system devices.
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