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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 NON-RATE RESPONSIVE PACEMAKERS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemakers & programmer systems
ApplicantELA MEDICAL, INC.
PMA NumberP900022
Supplement NumberS009
Date Received08/29/2007
Decision Date11/13/2007
Product Code
LWP[ Registered Establishments with LWP ]
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 smartview 2. 02 ug2 software as well as associated labeling and operator manual updates. The software modifications are intended to make minor software corrections (manager, ovation) and to include a downloadable ram patch (symphony/ rhapsody).
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