DELTA/VISTA PACEMAKERS
FDA premarket approval P910077/S029 · decided 1999-11-05
Approval details
- PMA number
- P910077
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DELTA/VISTA PACEMAKERS
- Generic name
- Implantable cardioverter defibrillator (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
- LWS
- 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 2901 PRM Programmers, to correct software anomalies and update features.
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