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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 NameRELAY/DASH/STRIDE/DART PACING SYSTEMS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator and programmer
Regulation Number870.3610
ApplicantINTERMEDICS, INC.
PMA NumberP910020
Supplement NumberS010
Date Received08/29/1995
Decision Date03/15/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate accelerometer.
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