ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
FDA premarket approval P900023/S023 · decided 1997-09-03
Approval details
- PMA number
- P900023
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 1997-06-19
- Decision date
- 1997-09-03
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Approval for use of a 42 French atrial and a 42 French arterial cannula to be used with the BVS 5000(R) Bi-Ventricular Support System.
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