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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 RF VR & RF DR ICD
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP980049
Supplement NumberS074
Date Received05/16/2012
Decision Date05/30/2012
Product Code MRM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
THE FOLLOWING CHANGES: 1) AN ALTERNATE REFLOW OVEN WITH AN UPDATED REFLOW SOLDERING PROFILE AND AN ALTERNATE COMPONENT CARRIER; 2) AN UPDATE TO THE REWORK PROCESS; 3) IN-SOURCING OF AN ELECTRONIC ASSEMBLY; 4) CLEAN ROOM LAYOUT MODIFICATION AT SALUGGIA, ITALY, PLANT, AND; 5)AN ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS.
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