VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD
FDA premarket approval P840068/S026 · decided 1996-04-16
Approval details
- PMA number
- P840068
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-06-26
- Decision date
- 1996-04-16
- Days to decision
- 295 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE CARDIAC PACEMAKER MODELS, PELLETHANE 2363-75D POLYURETHANE WITH TECOTHANE TT1075D-M POLYURETHANE
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