MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS

FDA premarket approval P980035/S035 · decided 2004-03-08

Approval details

PMA number

P980035

Supplement

S035

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

2004-02-12

Decision date

2004-03-08

Days to decision

25 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MODEL 2490D CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH ENPULSE AND KAPPA 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