PMA P830045S056

Device: APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S056
Product code: LWP
Decision date: 1998-09-04
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.

Current openFDA PMA Record

Device: APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S056
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1998-09-04
Decision code: APPR
Date received: 1998-03-13
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.