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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 NameORCHESTRA PROGRAMMER
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
PMA NumberP980049
Supplement NumberS013
Date Received02/20/2004
Decision Date03/16/2004
Product Code
MRM[ Registered Establishments with MRM ]
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 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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