ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS
FDA premarket approval P060027/S106 · decided 2025-11-25
Approval details
- PMA number
- P060027
- Supplement
- S106
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2023-12-21
- Decision date
- 2025-11-25
- Days to decision
- 705 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- 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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