PMA P890055S020
- Device
- CODMAN 3000 IMPLANTABLE INFUSION PUMP
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S020
- Product code
- LKK
- Decision date
- 2007-08-23
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- CHANGE 1) IN PACKAGING LOCATION FOR THE BARBED CATHETER CONNECTOR TO AN IN-HOUSE PROCEDURE AT CODMAN & SHURTLEFF, RAYNHAM, MASSACHUSETTS FROM AVID MEDICAL, ROANO, VIRGINIA, AND 2) CHANGE IN THE BARBED CATHETER CONNECTOR PACKAGING TO THE APPROVED PACKAGING FOR THE FLEX 1 REPLACEMENT CONNECTOR.
Current openFDA PMA Record#
- Device
- CODMAN 3000 IMPLANTABLE INFUSION PUMP
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S020
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2007-08-23
- Decision code
- OK30
- Date received
- 2007-08-06
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE 1) IN PACKAGING LOCATION FOR THE BARBED CATHETER CONNECTOR TO AN IN-HOUSE PROCEDURE AT CODMAN & SHURTLEFF, RAYNHAM, MASSACHUSETTS FROM AVID MEDICAL, ROANO, VIRGINIA, AND 2) CHANGE IN THE BARBED CATHETER CONNECTOR PACKAGING TO THE APPROVED PACKAGING FOR THE FLEX 1 REPLACEMENT CONNECTOR.