MEDTRONIC 2490C CARELINK MONITOR 2020A CARDIOSIGHT READER

FDA premarket approval P890003/S131 · decided 2008-03-17

Approval details

PMA number

P890003

Supplement

S131

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC 2490C CARELINK MONITOR 2020A CARDIOSIGHT READER

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2007-10-31

Decision date

2008-03-17

Days to decision

138 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR REMOVAL OF THE CONTRAINDICATION: ?PATIENTS WHOSE PRIMARY DISORDER IS BRADYARRHYTHMIA? AND FOR THE MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284DRG, MAXIMO II VR D284VRC, MODEL 9995 APPLICATION SOFTWARE VERSION 1.1 SYSTEMS, MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME: M

510(k) clearances by this applicant