PMA P010012

Device: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S566
Product code: NIK
Decision date: 2026-07-01
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: software changes for the LATITUDE NXT Patient Management System, Release 7.8

Current openFDA PMA Record#

Device: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S607
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-07-01
Decision code: APPR
Date received: 2026-04-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: software changes for the LATITUDE NXT Patient Management System, Release 7.8