VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052
FDA premarket approval P840068/S019 · decided 1996-06-19
Approval details
- PMA number
- P840068
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1992-05-05
- Decision date
- 1996-06-19
- Days to decision
- 1506 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR TWO NEW MODELS OF VISTA DDD PULSE GENERATORS AND A SOFTWARE MODULE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME VISTA DDD MODEL 942, VISTA DDD MODEL 944 AND SOFTWARE MODULE MODEL 2052 WITH THE COMMERCIALLY AVAILABLE HANDHELD PROGRAMMER MODEL 2035
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