MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

FDA premarket approval P970012/S001 · decided 1998-05-21

Approval details

PMA number

P970012

Supplement

S001

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

1998-04-06

Decision date

1998-05-21

Days to decision

45 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Approval for an update to the Medtronic.Vision Software Model 9952 - Series 2.0. The update will add the ability to program the Medtronic.Kappa 400 Models K(DR) 401/403, K(SR) 401/403, the Medtronic DX2 Models 7970/7972, and will add Electrophysiological Studies (EPS) capability to the Kappa 400 pacemakers. The update also incorporates performance enhancements which shorten boot and application load times, provide quicker screen transitions, and reporting and usability enhancements.

510(k) clearances by this applicant