PMA P910077S180

Device
LATITUDE™ NXT Patient Management System, LATITUDE™ Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NXT Syst
Applicant
Boston Scientific
Product code
LWS
Decision date
2020-10-22
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for software changes included in LATITUDE NXT Patient Management System Release 7.0.

Current openFDA PMA Record#

Device
LATITUDE™ NXT Patient Management System, LATITUDE™ Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NXT Syst
Applicant
Boston Scientific
PMA number
P910077
Supplement
S180
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2020-10-22
Decision code
APPR
Date received
2020-08-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software changes included in LATITUDE NXT Patient Management System Release 7.0.