PMA P060027

Device: ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS
Applicant: MicroPort CRM USA, Inc.
PMA number: P060027
Supplement: S105
Product code: NIK
Decision date: 2025-11-25
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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.

Current openFDA PMA Record#

Device: ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS
Applicant: MicroPort CRM USA, Inc.
PMA number: P060027
Supplement: S106
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2025-11-25
Decision code: APPR
Date received: 2023-12-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.