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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 NameRX 7000 PROGRAMMING SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameprogrammer, pacemaker
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP830026
Supplement NumberS074
Date Received10/09/1998
Decision Date02/18/1999
Product Code
LWP[ Registered Establishments with LWP ]
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 rx7000 programming system model 522-17 with r1. 00. 00 software. The device, as modified, will be marketed under the trade name rx7000 model 522-17 porgrammer and is indicated for the interrogation and programming of sulzer intermedics pulse generators.
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