PMA P900023S048
- Device
- AB5000 CIRCULATORY SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S048
- Product code
- DSQ
- Decision date
- 2007-12-21
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE A STATEMENT REGARDING ADDITIONAL IN VITRO RELIABILITY TESTING OF THE PUMP.
Current openFDA PMA Record#
- Device
- AB5000 CIRCULATORY SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S048
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2007-12-21
- Decision code
- APPR
- Date received
- 2007-04-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE A STATEMENT REGARDING ADDITIONAL IN VITRO RELIABILITY TESTING OF THE PUMP.