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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.
 
DeviceENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP130010
Supplement NumberS002
Date Received12/21/2023
Decision Date11/25/2025
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the ENERGYA/TALENTIA family of ICDs and CRT-Ds and associated SmartTouch Programmer software modules, and updates to the Remote Monitoring System.
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