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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.
 
DevicePlatinium VR 1210, Platinium VR 1240, ENERGYA VR 3110, TALENTIA VR 3210, ENERGYA VR 3140, TALENTIA VR 3240, Platinium DR
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP980049
Supplement NumberS147
Date Received04/18/2025
Decision Date07/23/2025
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of Mylar spacers to our ALIZEA/CELEA pacemakers, allow hybrid tab replacements to occur at Microport’s Saluggia, Italy facility, and changes in manufacturing processes of other MicroPort’s pacemaker, ICD, and CRT-D systems.
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