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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 NumberS011
Date Received09/05/1995
Decision Date03/22/1996
Withdrawal Date07/20/2012
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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