PMA P910077S157

Device
LATITUDE™ NXT Patient Management System, LATITUDE Wave Communicator
Applicant
Boston Scientific
PMA number
P910077
Supplement
S157
Product code
LWS
Decision date
2017-02-16
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for Model 6290 Patient Communicator software update to version 2.22.00.

Current openFDA PMA Record#

Device
LATITUDE™ NXT Patient Management System, LATITUDE Wave Communicator
Applicant
Boston Scientific
PMA number
P910077
Supplement
S157
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2017-02-16
Decision code
APPR
Date received
2016-11-22
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for Model 6290 Patient Communicator software update to version 2.22.00.