MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD

FDA premarket approval P890003/S050 · decided 1998-06-03

Approval details

PMA number

P890003

Supplement

S050

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

1997-05-05

Decision date

1998-06-03

Days to decision

394 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Approval for new pacing lead models. The devices, as modified, will be marketed under the trade names: Medtronic Models 5038-58, 5038-65, 5038-52, 5038S-58, and 5038L-65 CapSure VDd-2 and Vitatron Models IMW 14Q/15Q/16Q/17Q/18Q Brilliant S+ VDD Pacing Leads and are indicated for bipolar sensing in the atrium and bipolar sensing and pacing in the ventricle when used with current Medtronic(R) VDD pacemakers.

510(k) clearances by this applicant