PMA P830045S064
- Device
- Model 3510 Programmer/3303 Software
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P830045
- Supplement
- S064
- Decision date
- 1999-04-21
Current openFDA PMA Record
- Device
- MODEL 3510 PROGRAMMER/3303 SOFTWARE
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P830045
- Supplement
- S064
- Product code
- KRG
- Generic name
- Programmer, pacemaker
- Decision date
- 1999-04-21
- Decision code
- APPR
- Date received
- 1999-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers.