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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 NameSYNCHRONY II MODELS 2022T & 2023M - 2002T & 2003M
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantPACESETTER SYSTEMS
PMA NumberP880086
Supplement NumberS005
Date Received11/13/1989
Decision Date01/18/1990
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
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