PMA P910077S186

Device: LATITUDE Programming System
Applicant: Boston Scientific
PMA number: P910077
Supplement: S186
Product code: LWS
Decision date: 2021-11-30
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Approval for a software maintenance release (SMR) to the Model 3300 LATITUDE Programming System and the release of the Model 3894 LATITUDE Consult software application.

Current openFDA PMA Record#

Device: LATITUDE Programming System
Applicant: Boston Scientific
PMA number: P910077
Supplement: S186
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2021-11-30
Decision code: APPR
Date received: 2021-09-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a software maintenance release (SMR) to the Model 3300 LATITUDE Programming System and the release of the Model 3894 LATITUDE Consult software application.