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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 & ELA RHAPSODY PACEMAKERS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS021
Date Received10/07/2004
Decision Date10/27/2004
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the labeling for the symphony and ela rhapsody pacemakers to include instructions about testing, sensing or pacing while the pacemaker is out of the pocket.
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