PMA P910077S182

Device: LATITUDE Programming System
Applicant: Boston Scientific
PMA number: P910077
Supplement: S182
Product code: LWS
Decision date: 2021-02-02
Generic name: Implantable cardioverter defibrillator (non-CRT)
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: LATITUDE Programming System
Applicant: Boston Scientific
PMA number: P910077
Supplement: S182
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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.