PMA P940031S016
- Device
- MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S016
- Product code
- LWP
- Decision date
- 1998-10-02
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for changes to the Model 2890 Software Application from Version 1.20 to Version 2.12 which consist primarily of usability changes (screen changes, usability features), corrections of anomalies, and the addition of a high rate single chamber temporary pacing mode (up to 380 ppm) to the DISCOVERY(TM)/MERIDIAN(TM) pacemakers which provides consistency with the VIGOR pacemakers.
Current openFDA PMA Record#
- Device
- MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S016
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1998-10-02
- Decision code
- APPR
- Date received
- 1998-08-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Model 2890 Software Application from Version 1.20 to Version 2.12 which consist primarily of usability changes (screen changes, usability features), corrections of anomalies, and the addition of a high rate single chamber temporary pacing mode (up to 380 ppm) to the DISCOVERY(TM)/MERIDIAN(TM) pacemakers which provides consistency with the VIGOR pacemakers.