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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 III AND PARAGON III DUAL-CHAMBER PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantSIEMENS-PACESETTER, INC.
PMA NumberP880086
Supplement NumberS032
Date Received08/02/1995
Decision Date11/01/1995
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternative hybrid substrate.
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