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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
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
PMA NumberP980049
Supplement NumberS002
Date Received07/06/2000
Decision Date11/13/2000
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for orchestra programmer with the following application software packages: manager software application version 1. 02, cso a programmer application version 2. 21, cso-windows programmer application version 1. 03, defender ii programmer application version 2. 03, and defender iv programmer application version 1. 03.
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