FDA.reportPublic FDA data

PMA P910077S174

Device
Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS)
Applicant
Boston Scientific
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 softwareMultiple Application Utility and Data Manager.

Current openFDA PMA Record#

Device
Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS)
Applicant
Boston Scientific
PMA number
P910077
Supplement
S174
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 softwareMultiple Application Utility and Data Manager.