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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 NameSENSOLOG(R) CARDIAC PACING SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantSIEMENS-PACESETTER, INC.
PMA NumberP880006
Supplement NumberS022
Date Received01/30/1995
Decision Date12/06/1996
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 an alternative sterilization cycle and a new sterilization site at the solna, sweden, manufacturing site.
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