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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 S.r.l.
Via Crescentino S.N.
Saluggia 13040
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
Predetermined Change Control Plan AuthorizedNo
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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