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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRELAY/DASH/STRIDE/DART PACING SYSTEMS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910020
Supplement NumberS014
Date Received02/01/1996
Decision Date03/03/1996
Withdrawal Date07/20/2012
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF LABELING ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:RELAY:293-03/294-03/294-03R -- DASH:291-03/292-03/292-03R -- STRIDE:294-05 -- DART:292-05 -- UNITY-C:292-06
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