ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
FDA premarket approval P900023/S042 · decided 2005-03-23
Approval details
- PMA number
- P900023
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2004-12-22
- Decision date
- 2005-03-23
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR A CHANGE TO ONLY THE AB5000 CIRCULATORY SUPPORT SYSTEM THAT WILL ALLOW THE USER AN ALTERNATE MEANS OF REDUCING BLOOD FLOW DURING WEANING BY ADJUSTING THE LEVEL OF VACUUM APPLIED TO THE AB5000 BLOOD PUMP.
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