DELTA/VISTA
FDA premarket approval P840068/S040 · decided 2000-12-13
Approval details
- PMA number
- P840068
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DELTA/VISTA
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-07-25
- Decision date
- 2000-12-13
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VENTAK(R) AV DDD/ AV II DDD MODEL 2833 VERSION 4.0 SOFTWARE, THE VENTAK(R) VR MODEL 2841 VERSION 4.0 SOFTWARE AND THE DELTA(R)/ VISTA MODEL 2881 VERSION 2.0 SOFTWARE.
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