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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.
 
DeviceVARIOUS MODELS OF RATE-RESPONSIVE PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP950029
Supplement NumberS025
Date Received01/30/2006
Decision Date03/15/2006
Product Code NVZ 
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 HARDWARE MODIFICATION OF THE CPR3 PROGRAMMING HEAD TO BE USED WITH ALL THE ELA?S ICD AND PACEMAKER SYSTEMS.
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