PMA P880086S103

Device: PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S103
Product code: DXY
Decision date: 2005-04-06
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order 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.

Current openFDA PMA Record#

Device: PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S103
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2005-04-06
Decision code: APPR
Date received: 2005-02-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.