PMA P880006S029

Device: REGENCY SC+, REGENCY SC, REGENCY SCX
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S029
Product code: DXY
Decision date: 2000-01-28
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrogation of implanted St. Jude pacemakers.

Current openFDA PMA Record

Device: REGENCY SC+, REGENCY SC, REGENCY SCX
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S029
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2000-01-28
Decision code: APPR
Date received: 1999-07-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrogation of implanted St. Jude pacemakers.