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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 LEADS AND ACCESSORIES
Generic Namepermanent pacemaker Electrode
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960004
Supplement NumberS021
Date Received11/13/2002
Decision Date12/13/2002
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
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