DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
FDA premarket approval P840068/S036 · decided 1998-07-31
Approval details
- PMA number
- P840068
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-06-24
- Decision date
- 1998-07-31
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for an update to the Model 2881 Software Application to include the DELTA/VISTA pacemakers, series, resulting in Version 1.3 of the Model 2881 Software Application.
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