PMA P960040S513

Device: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA
Applicant: Boston Scientific
PMA number: P960040
Supplement: S513
Product code: LWS
Decision date: 2026-07-01
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: software changes for the LATITUDE NXT Patient Management System, Release 7.8

Current openFDA PMA Record#

Device: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA
Applicant: Boston Scientific
PMA number: P960040
Supplement: S513
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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