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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 PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS024
Date Received07/05/2005
Decision Date09/02/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following software updates: 1) aaisafer ram patch 2. 3 for symphony dr 2550 devices with rom mask t3, 2) rom mask t4 for symphony dr 2550, symphony sr 2250, ela rhapsody+ dr 2530, ela rhapsody dr 2510, and ela rhapsody sr 2210, 3) elaview 1. 30 ug2 application software for the orchestra programmer.
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