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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.
 
DeviceSMARTVIEW
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP900022
Supplement NumberS010
Date Received03/05/2008
Decision Date03/18/2008
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 THE SMARTVIEW 2.02 UG3 SOFTWARE. THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS AND TO ADD THE PACEART XML CONVERTER TO THE SMARTVIEW 2.02 UG2 SOFTWARE.
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