ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
FDA premarket approval P900023/S025 · decided 1998-03-13
Approval details
- PMA number
- P900023
- Supplement
- S025
- 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
- 1997-11-24
- Decision date
- 1998-03-13
- Days to decision
- 109 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Approval for four new 32 French atrial cannulae which are 90 degrees Bend with Lighthouse Tip, Straight with Lighthouse Tip, 90 degrees Bend with Beveled Tip, and Straight with Beveled Tip.
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