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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 NameAPSU PROGRAMMER, APSU SOFTWARE, BASE STATION
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemaker programmer and base station
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP880006
Supplement NumberS027
Date Received03/13/1998
Decision Date09/04/1998
Product Code
DXY[ Registered Establishments with DXY ]
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 pacesetter ab, st. Jude medical cardiac rhythm management division, veddestavagen 19, jarfalla, sweden.
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