CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND ACESSORIES
FDA premarket approval P890055/S038 · decided 2012-01-17
Approval details
- PMA number
- P890055
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND ACESSORIES
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2011-12-21
- Decision date
- 2012-01-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- MANUFACTURING PROCESS CHANGE TO THE DEVICE USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP.
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