PMA P880006S026

Device: APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S026
Product code: DXY
Decision date: 1998-05-07
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval for the Regency SC+, Regency SC, and Regency SCX Pulse Generators which are programmed by the APS II Programmer with Model 3204a Function Pack.

Current openFDA PMA Record

Device: APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S026
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1998-05-07
Decision code: APPR
Date received: 1998-02-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Regency SC+, Regency SC, and Regency SCX Pulse Generators which are programmed by the APS II Programmer with Model 3204a Function Pack.