PMA P030005S197

Device: (CRT-P Resynchronization Devices) INVIVE, INTUA, VISIONIST, VALITUDE
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S197
Product code: NKE
Decision date: 2020-06-15
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
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-P Resynchronization Devices) INVIVE, INTUA, VISIONIST, VALITUDE
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S197
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2020-06-15
Decision code: APPR
Date received: 2020-03-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.