FDA.reportPublic FDA data

PMA P910077S177

Device
LATITUDE Programming System, Altrua/Insignia I/Nexus I
Applicant
Boston Scientific
Product code
LWS
Decision date
2020-06-15
Generic name
Implantable cardioverter defibrillator (non-CRT)
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
LATITUDE Programming System, Altrua/Insignia I/Nexus I
Applicant
Boston Scientific
PMA number
P910077
Supplement
S177
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
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.