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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 NameRX5000 PROGRAMMER
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameprogrammer, pacemaker
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP830026
Supplement NumberS076
Date Received10/07/1999
Decision Date10/29/1999
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the as shipped configuration for refurbished and repaired rx5000 pacemaker programmers. Specifically, to offer the triangular chest lead cable model 526-04 as a purchasable accessory and no longer include it with the shipped units.
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