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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 NameELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
PMA NumberP980049
Supplement NumberS017
Date Received09/15/2004
Decision Date12/08/2004
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 the elaview 1. 26 ug application software for the orchestra programmer; ram patches alto p4 and alto2 p3; and hso 2. 70 software for the cpr3 programming head.
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