CODMAN 3000 IMPLANTABLE INFUSION PUMP
FDA premarket approval P890055/S020 · decided 2007-08-23
Approval details
- PMA number
- P890055
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Trade name
- CODMAN 3000 IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2007-08-06
- Decision date
- 2007-08-23
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- 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.
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