ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM
FDA premarket approval P900023/S033 · decided 2000-06-22
Approval details
- PMA number
- P900023
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2000-05-10
- Decision date
- 2000-06-22
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR A 36 FRENCH POLYURETHANE ARTERIAL CANNULA WITH A STAINLESS STEEL WIRE REINFORCED COIL AND A 10 MM HEMASHIELD(R) GRAFT.
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