PMA P900023S021
- Device
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S021
- Product code
- DSQ
- Decision date
- 1997-04-16
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR AN INCREASE IN THE STERILIZER LOAD SIZE.
Current openFDA PMA Record#
- Device
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S021
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1997-04-16
- Decision code
- APPR
- Date received
- 1997-03-27
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN INCREASE IN THE STERILIZER LOAD SIZE.