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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.
 
DeviceVITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960040
Supplement NumberS055
Date Received05/26/2005
Decision Date06/14/2005
Product Codes KRG LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
USE OF AN ALTERNATE EPOXY IN THE MANUFACTURE OF POWER MODULES FOR THE VITALITY FAMILY OF ICDS AND THE CONTAK RENEWAL FAMILY OF CRT-D DEVICES.
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