CODMAN SERIES 3000 IMPLANTABLE INFUSION PUMPS
FDA premarket approval P890055/S018 · decided 2004-03-25
Approval details
- PMA number
- P890055
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CODMAN SERIES 3000 IMPLANTABLE INFUSION PUMPS
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2004-03-22
- Decision date
- 2004-03-25
- Days to decision
- 3 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR THE FOLLOWING: MINOR DESIGN AND MATERIAL MODIFICATIONS TO THE CONNECTOR; ADDITION OF A SILICONE STRAIN RELIEF SLEEVE; AND MINOR DESIGN AND MATERIAL MODIFICATIONS TO THE ANCHORS.
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