2490D/E CARELINK MONITORS

FDA premarket approval P890003/S078 · decided 2004-10-25

Approval details

PMA number

P890003

Supplement

S078

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

2490D/E CARELINK MONITORS

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

2004-10-05

Decision date

2004-10-25

Days to decision

20 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MODEL 2490E & 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH INSYNC II PROTECT MODEL 7295, INSYNC MAXIMO MODEL 7303, ONYX VR MODEL 7290CX, INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES. THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.

510(k) clearances by this applicant