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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.
 
DevicePARADYM ICDS AND CRT-D DEVICES
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP060027
Supplement NumberS028
Date Received08/12/2010
Decision Date09/08/2010
Product Code NIK 
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 DESIGN CHANGES FOR LOW VOLTAGE ELECTRONIC HYBRID MODULE AND INTERCONNECTION FLEX CIRCUIT FOR PARADYM VR/DR AND CRT-D, MODELS 8250, 8550, AND 8750.
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