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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
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/material
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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