PMA P910077S185

Device
LATITUDE™ NXT Remote Patient Management System, LATITUDE™Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NX
Applicant
Boston Scientific
PMA number
P910077
Supplement
S185
Product code
LWS
Decision date
2021-09-17
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for the software modifications to the LATITUDE NXT Remote Patient Management System.

Current openFDA PMA Record#

Device
LATITUDE™ NXT Remote Patient Management System, LATITUDE™Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NX
Applicant
Boston Scientific
PMA number
P910077
Supplement
S185
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2021-09-17
Decision code
APPR
Date received
2021-06-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the software modifications to the LATITUDE NXT Remote Patient Management System.