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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 NumberS011
Date Received09/05/1995
Decision Date03/22/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the change in sterilant from amixture of 12% ethylene oxide and 88% freon to a mixture of 8. 5% ethylene oxide and 91. 5% carbon dioxide.
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