Codman 3000 Refill Kit
FDA premarket approval P890055/S067 · decided 2017-08-14
Approval details
- PMA number
- P890055
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Codman 3000 Refill Kit
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2017-05-16
- Decision date
- 2017-08-14
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for a material change to components of the Cadman 3000 Refill Kit.
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