VITATRON DA+ C SERIES PULSE GENERATORS

FDA premarket approval P990001/S014 · decided 2003-09-16

Approval details

PMA number

P990001

Supplement

S014

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

VITATRON DA+ C SERIES PULSE GENERATORS

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

2003-02-20

Decision date

2003-09-16

Days to decision

208 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR MODIFICATIONS TO RATE RESPONSE FEATURES, ADDITION OF TELEMETRY B, AND OTHER DIAGNOSTIC ENHANCEMENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/VITATRON DA+ C-SERIES IMPLANTABLE GENERATORS AND IS INDICATED AS FOLLOWS: 1) DUAL CHAMBER PACING IS INDICATED IF AV SYNCHRONY NEEDS TO BE RESTORED IN ORDER TO OPTIMIZE CARDIAC OUTPUT. FOR EXAMPLE, PATIENTS WITH SYMPTOMATIC SECOND OR THIRD DEGREE AV BLOCK. 2) DUAL CHAMBER RATE RESPONSIVE PACING MODES ARE OF SPECI

510(k) clearances by this applicant