PMA P910077S152

Device
LATITUDE NXT RELEASE 4.1.1
Applicant
Boston Scientific
PMA number
P910077
Supplement
S152
Product code
LWS
Decision date
2016-07-08
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for LATITUDE NXT Patient Management System, Release 4.1.1.

Current openFDA PMA Record#

Device
LATITUDE NXT RELEASE 4.1.1
Applicant
Boston Scientific
PMA number
P910077
Supplement
S152
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2016-07-08
Decision code
APPR
Date received
2016-04-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for LATITUDE NXT Patient Management System, Release 4.1.1.