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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
ApplicantGUIDANT INTERMEDICS
PMA NumberP830026
Supplement NumberS075
Date Received09/07/1999
Decision Date09/24/1999
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at benchmark electronics, 4065 theurer blvd. , winona, mn 55987.
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