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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.
 
DeviceORCHESTRA PROGRAMMER
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS013
Date Received02/20/2004
Decision Date03/16/2004
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR ELAVIEW 1.22 UG1 APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER, RAM PATCH P2 FOR ALTO 2 ICD SYSTEM, RAM PATCH TI V5 FOR SYMPHONY AND ELA RHAPSODY PACEMAKERS, AND HSO 2.68 SOFTWARE AND V10+ HARDWARE FOR THE CPR3 PROGRAMMING HEAD.
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