PMA P150012S131

Device: Pacemaker Devices
Applicant: Boston Scientific
Product code: LWP
Decision date: 2022-12-20
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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: Pacemaker Devices
Applicant: Boston Scientific
PMA number: P150012
Supplement: S131
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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).