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. |
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Device | ORCHESTRA PROGRAMMER |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S013 |
Date Received | 02/20/2004 |
Decision Date | 03/16/2004 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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