PMA P900023S050
- Device
- ABIOMED ARTERIAL CANNULA
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S050
- Product code
- DSQ
- Decision date
- 2008-09-18
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- CHANGE FROM A COATING PROCEDURE PERFORMED AT AN OUTSIDE VENDOR TO A COATING PROCEDURE PERFORMED AT ABIOMED.
Current openFDA PMA Record#
- Device
- ABIOMED ARTERIAL CANNULA
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S050
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2008-09-18
- Decision code
- OK30
- Date received
- 2008-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM A COATING PROCEDURE PERFORMED AT AN OUTSIDE VENDOR TO A COATING PROCEDURE PERFORMED AT ABIOMED.