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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 CD, CONTAK CD 2, EASYTRAK, EASYTRACK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS034
Date Received10/21/2004
Decision Date11/19/2004
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
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