ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
FDA premarket approval P900023/S027 · decided 1998-05-28
Approval details
- PMA number
- P900023
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 1998-04-02
- Decision date
- 1998-05-28
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Approval for a change in the manufacturing process to allow the outflow connector to be annealed prior to assembly of the blood pump.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.