PMA P010012S529

Device: Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill
Applicant: Boston Scientific Corp
Product code: NIK
Decision date: 2021-02-02
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for a software maintenance release for the Model 3892 Altrua, Insignia I, and Nexus I software application on the Model 3300 LATITUDE Programming System.

Current openFDA PMA Record#

Device: Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S529
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2021-02-02
Decision code: APPR
Date received: 2020-11-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a software maintenance release for the Model 3892 Altrua, Insignia I, and Nexus I software application on the Model 3300 LATITUDE Programming System.