DELTA/VISTA PACEMAKERS
FDA premarket approval P840068/S038 · decided 1999-11-05
Approval details
- PMA number
- P840068
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DELTA/VISTA PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-10-06
- Decision date
- 1999-11-05
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for modifications to the Programmer Software Model 2881 version 1.3 and its labeling, used with the Model 2950 and Model 2901 PRM Prorammers, to correct software anomalies and update features.
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