AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM
FDA premarket approval P900023/S046 · decided 2007-04-24
Approval details
- PMA number
- P900023
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2006-10-26
- Decision date
- 2007-04-24
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE AB5000 VENTRICLE CANNULA RESTRAINT SYSTEM, EXTENDED SHELF LIFE (2 YEARS) FOR THE AB5000 VENTRICLE, AND RECLASSIFICATION OF A PRECAUTION TO A WARNING FOR THE BVS 5000.
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