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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 FAMILY (INCLUDES SELUTE, SELUTE PICOTIP)
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP950001
Supplement NumberS014
Date Received02/24/2005
Decision Date03/24/2005
Product Code DTB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
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