PMA P900023S017
- Device
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S017
- Product code
- DSQ
- Decision date
- 1995-11-30
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE ADDITION OF REFERENCE CARDS TO BE PLACED IN A HOLDER ATTACHED TO THE CONSOLE
Current openFDA PMA Record#
- Device
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S017
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1995-11-30
- Decision code
- APPR
- Date received
- 1995-10-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF REFERENCE CARDS TO BE PLACED IN A HOLDER ATTACHED TO THE CONSOLE