42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF
FDA premarket approval P900023/S044 · decided 2006-07-07
Approval details
- PMA number
- P900023
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2006-01-05
- Decision date
- 2006-07-07
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR DESIGN CHANGES TO INTEGRATE THE PREVIOUSLY APPROVED 42 FR. VENTRICULAR/ATRIAL CANNULA AND PREVIOUSLY APPROVED SEWING CUFF ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 42 FR. VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF AND IS INDICATED FOR USE WITH THE BVS 5000 BIVENTRICULAR SUPPORT SYSTEM AND WITH THE AB5000 CIRCULATORY SUPPORT SYSTEM.
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