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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.
 
DevicePROGRAMMER SOFTWARE APPLICAION MODEL 2812, VERSION 2.1
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960040
Supplement NumberS084
Date Received08/25/2005
Decision Date03/23/2007
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR VITALITY AVT PROGRAMMER SOFTWARE (SW) MODEL 2812V2.1 AND THE APPLICABLE FIRMWARE FOR USE ON TE MODEL 3120 PROGRAMMER.
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