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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 NameALL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
PMA NumberP980049
Supplement NumberS025
Date Received01/24/2007
Decision Date06/29/2007
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the orchestra plus programmer and elaview 2. 02 programming software.
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