MEDTRONIC KAPPA/SIGMA PACEMAKER FAMILIES

FDA premarket approval P980035/S022 · decided 2002-03-13

Approval details

PMA number

P980035

Supplement

S022

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC KAPPA/SIGMA PACEMAKER FAMILIES

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

2002-02-27

Decision date

2002-03-13

Days to decision

14 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROG

510(k) clearances by this applicant