- Device
- 3500/3510 PROGRAMMER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S067
- 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 3510 Programmers. The device is indicated for programming and interrogation of implanted St. Jude pacemakers.