PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,

FDA premarket approval P880086/S103 · decided 2005-04-06

Approval details

PMA number

P880086

Supplement

S103

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

2005-02-22

Decision date

2005-04-06

Days to decision

43 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR PRE-MOLDED HEADER DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380, IDENTITY ADX VDR MODEL 5480, AND INTEGRITY ADX DR MODEL 5360.

510(k) clearances by this applicant