MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)

FDA premarket approval P980035/S026 · decided 2003-02-25

Approval details

PMA number

P980035

Supplement

S026

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

2003-01-27

Decision date

2003-02-25

Days to decision

29 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) WHICH ARE INDICATED FOR USE BY THE 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