PMA P890055S019
- Device
- CODMAN 3000 PUMP SILICONE CATHETER
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S019
- Product code
- LKK
- Decision date
- 2006-10-19
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL TO CHANGE THE MATERIAL OF THE THREE SILICONE BEADS ATTACHED TO THE DISTAL END OF THE PUMP CATHETER DURING MANUFACTURE TO A DIFFERENT SILICONE, NUSIL MED-4850 (SSF-MLTN-850 45-55).
Current openFDA PMA Record#
- Device
- CODMAN 3000 PUMP SILICONE CATHETER
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S019
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2006-10-19
- Decision code
- APPR
- Date received
- 2006-09-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO CHANGE THE MATERIAL OF THE THREE SILICONE BEADS ATTACHED TO THE DISTAL END OF THE PUMP CATHETER DURING MANUFACTURE TO A DIFFERENT SILICONE, NUSIL MED-4850 (SSF-MLTN-850 45-55).