MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953-SERIES 1.1 SOFTWARE

FDA premarket approval P980035/S001 · decided 1999-04-01

Approval details

PMA number

P980035

Supplement

S001

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953-SERIES 1.1 SOFTWARE

Applicant

Medtronic, Inc.

Date received

1999-03-10

Decision date

1999-04-01

Days to decision

22 days

Decision code

APPR

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Approval for the Medtronic.Vision Software Models 9953 and 9953A (Series 1.3) for use with the Medtronic Model 9790 programmers to program the Medtronic Kappa 700 series pacemakers. The device, as modified, will be marketed under the trade name Medtronic.Vision Software Models 9953/9953A and is indicated for use with the Medtronic Kappa 700 series pacemakers to allow electrophysiology stimulation (EPS) functions.

510(k) clearances by this applicant