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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.
 
DeviceEDGEBAND PACER RELAY MODEL 294-03E
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910020
Supplement NumberS018
Date Received06/09/1997
Decision Date11/18/1997
Withdrawal Date07/20/2012
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Relay Model 294-03E edgeband pulse generator.
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