ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM
FDA premarket approval P900023/S052 · decided 2012-06-26
Approval details
- PMA number
- P900023
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2011-10-06
- Decision date
- 2012-06-26
- Days to decision
- 264 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR CORRECTION OF THE AB5000 DRIVER FAILURE NOTIFICATION ALARM, ADDITION OF A DELAY CIRCUIT TO THE EXTERNAL AB PORTABLE POWER SUPPLY, AND CORRECTION TO THE IPULSE DRIVER PLENUM SEAL.
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