PMA P010012S518

Device: (CRT-D Resynchronization Devices) COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTU
Applicant: Boston Scientific Corp
Product code: NIK
Decision date: 2020-06-15
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for Model 3892 Altrua/Insignia/Nexus I Software Support Application v 1.04, Model 3909 Multiple Application Utility v 1.09, Model 3920 Platform Operating System v1.08, Model 3923 Quick Start Application v1.05 software applications of the Model 3300 LATTITUDE Programming System.

Current openFDA PMA Record#

Device: (CRT-D Resynchronization Devices) COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTU
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S518
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2020-06-15
Decision code: APPR
Date received: 2020-03-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for Model 3892 Altrua/Insignia/Nexus I Software Support Application v 1.04, Model 3909 Multiple Application Utility v 1.09, Model 3920 Platform Operating System v1.08, Model 3923 Quick Start Application v1.05 software applications of the Model 3300 LATTITUDE Programming System.