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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.
 
DeviceTHINLINE/FINELINE ENDOCARDIAL PACING LEADS
Generic Namepermanent pacemaker Electrode
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960004
Supplement NumberS011
Date Received01/11/2000
Decision Date02/23/2000
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to market all previously marketed Intermidics shylets kits under new Guidant modelnumbers and provide an alternate stylet kit package insert.
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