MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
FDA premarket approval P940031/S013 · decided 1998-05-28
Approval details
- PMA number
- P940031
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-05-07
- Decision date
- 1998-05-28
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software.
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