CODMAN 3000 PUMP SILICONE CATHETER
FDA premarket approval P890055/S019 · decided 2006-10-19
Approval details
- PMA number
- P890055
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CODMAN 3000 PUMP SILICONE CATHETER
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2006-09-28
- Decision date
- 2006-10-19
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- 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).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.