FDA.reportPublic FDA data

PMA P010012S514

Device
CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM
Applicant
Boston Scientific Corp
Product code
NIK
Decision date
2020-04-01
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
Approval for software changes included in LATITUDE NXT Patient Management System, Release 6.1.5 and associated changes in Server and Communicator software updates.

Current openFDA PMA Record#

Device
CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S514
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2020-04-01
Decision code
APPR
Date received
2020-01-03
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 6.1.5 and associated changes in Server and Communicator software updates.