- Device
- APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S045
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- 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.