PMA P890055S067
- Device
- Codman 3000 Refill Kit
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S067
- Product code
- LKK
- Decision date
- 2017-08-14
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for a material change to components of the Cadman 3000 Refill Kit.
Current openFDA PMA Record#
- Device
- Codman 3000 Refill Kit
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S067
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2017-08-14
- Decision code
- APPR
- Date received
- 2017-05-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a material change to components of the Cadman 3000 Refill Kit.