CRT-D Resynchronization Devices

FDA premarket approval P010012/S559 · decided 2022-12-20

Approval details

PMA number

P010012

Supplement

S559

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

CRT-D Resynchronization Devices

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

Boston Scientific Corp

Date received

2022-09-29

Decision date

2022-12-20

Days to decision

82 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

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).

510(k) clearances by this applicant