PMA P010012S559

Device: CRT-D Resynchronization Devices
Applicant: Boston Scientific Corp
Product code: NIK
Decision date: 2022-12-20
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for hardware and software changes to the LATITUDE NXT Patient Management System Communicator (Models 6280/6498 and 6290) required for the removal of the telephone modem (POTS plain old telephone service).

Current openFDA PMA Record#

Device: CRT-D Resynchronization Devices
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S559
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2022-12-20
Decision code: APPR
Date received: 2022-09-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for hardware and software changes to the LATITUDE NXT Patient Management System Communicator (Models 6280/6498 and 6290) required for the removal of the telephone modem (POTS plain old telephone service).