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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.
 
DeviceSELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP950001
Supplement NumberS002
Date Received04/03/1997
Decision Date09/19/1997
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site lcoated at Cardiac pacemakers, Inc., Del Caribe, Road 698 Lot No. 12, Dorado, PR 00646.
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