PMA P840068S035
- Device
- DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S035
- Product code
- LWP
- Decision date
- 1998-05-28
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software.
Current openFDA PMA Record#
- Device
- DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S035
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1998-05-28
- Decision code
- APPR
- Date received
- 1998-05-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software.