PMA P900023S049
- Device
- AB PORTABLE DRIVER
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S049
- Product code
- DSQ
- Decision date
- 2009-03-17
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR IN-HOSPITAL USE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- AB PORTABLE DRIVER
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S049
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2009-03-17
- Decision code
- APPR
- Date received
- 2008-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR IN-HOSPITAL USE OF THE DEVICE.