PMA P910077S149

Device
LATITUDE NXT PATIENT MANAGEMENT SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S149
Product code
OSR
Decision date
2015-07-21
Classification
Pacemaker/icd/crt Non-implanted Components
Generic name
Pacemaker/icd/crt non-implanted components
Approval order statement
APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).

Current openFDA PMA Record#

Device
LATITUDE NXT PATIENT MANAGEMENT SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S149
Product code
OSR
Generic name
Pacemaker/icd/crt non-implanted components
Decision date
2015-07-21
Decision code
APPR
Date received
2015-04-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).