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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.
 
DeviceCONTAK RENEWAL FAMILY
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS149
Date Received03/13/2007
Decision Date03/29/2007
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES FOR THE VITALITY AND CONTAK RENEWAL FAMILIES OF DEFIBRILLATORS: 1) REQUIRE THE REED SWITCH COMPONENT SUPPLIER TO EXPOSE 100% OF THE COMPONENTS TO A HIGH MAGNETIC FIELD CONDITION OF MINIMUM OF 30MT, 10 CYCLES WITH 1 SECOND DURATION PRIOR TO SHIPPING TO GUIDANT. 2) APPLY AN ENHANCED QUALITY TEST OF 30MT THROUGH 30 CYCLES AND VERIFY THE REED SWITCH IS OPEN AFTER REMOVING THE DEVICE FROM THE MAGNETIC FIELD, TO ALL DEVICES CURRENTLY HELD UNDER A STOP ACTION NOTICE (SAN).
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