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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 VR 8750, PARADYM DR 8750, PARADYM RF CRT-D
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP980049
Supplement NumberS093
Date Received02/12/2014
Decision Date04/09/2014
Product Code LWS 
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 MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES.
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