FDA.reportPublic FDA data

PMA P110042S129

Device
EMBLEM S-ICD Automated Screening Tool
Applicant
Boston Scientific Corporation
Product code
LWS
Decision date
2019-12-16
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for the Automatic Screening Tool on the Model 3300 LATITUDE Programming System and associated changes to the existing programming system support software Multiple Application Utility and Data Manager.

Current openFDA PMA Record#

Device
EMBLEM S-ICD Automated Screening Tool
Applicant
Boston Scientific Corporation
PMA number
P110042
Supplement
S129
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2019-12-16
Decision code
APPR
Date received
2019-10-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the Automatic Screening Tool on the Model 3300 LATITUDE Programming System and associated changes to the existing programming system support software Multiple Application Utility and Data Manager.