VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

FDA premarket approval P880086/S098 · decided 2004-01-30

Approval details

PMA number

P880086

Supplement

S098

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

2003-12-02

Decision date

2004-01-30

Days to decision

59 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL TO MODIFY THE HEADER DESIGN OF A CURRENTLY MARKETED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERITY ADX XL VDR MODEL 5456I AND IS INDICATED AS FOLLOWS: THE VERITY ADX XL VDR MODEL 5456I IS INDICATED FOR USE ONLY WITH AV PLUS MODEL 1328C OR 1358C SINGLE-PASS IN-LINE QUADRIPOLAR LEADS (THE VERITY ADX XL VDR PACING SYSTEM). THE VERITY ADX XL VDR PACING SYSTEM IS INTENDED TO PROVIDE VDD OR VDDR PACING FOR PATIENTS WITH A HEALTHY SINUS NODE AND AV CONDUCTION ABN

510(k) clearances by this applicant