PMA P980049S146

Device: ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S146
Product code: MRM
Decision date: 2025-11-25
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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: P980049
Supplement: S146
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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.