ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
FDA premarket approval P900023/S038 · decided 2003-09-24
Approval details
- PMA number
- P900023
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- 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
- 2003-01-27
- Decision date
- 2003-09-24
- Days to decision
- 240 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR THE AB5000 BLOOD PUMP, USED ONLY WITH THE AB5000 CONSOLE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM AND IS INDICATED FOR USE IN PATIENTS SUFFERING FROM REVERSIBLE VENTRICULAR DYSFUNCTION. THESE ARE PATIENTS WHO HAVE UNDERGONE SUCCESSFUL CARDIAC SURGERY AND SUBSEQUENTLY DEVELOP LOW CARDIAC OUTPUT, OR PATIENTS WHO SUFFER FROM ACUTE CARDIAC DISORDERS LEADING TO HEMODYNAMIC INSTABILITY. THE INTENT OF AB5000 SYSTEM THERAPY IS
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