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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.
 
DeviceSWEET TIP RX,SWEET PICOTIP RX,FLEXTEND
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960006
Supplement NumberS010
Date Received04/14/2004
Decision Date05/14/2004
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 IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
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