|
Device | CRT-D Resynchronization Devices |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S559 |
Date Received | 09/29/2022 |
Decision Date | 12/20/2022 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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). |