PMA P890055S023
- Device
- CODMAN 3000 IMPLANTABLE INFUSION PUMP
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S023
- Product code
- LKK
- Decision date
- 2007-11-26
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT AND TO THE CODMAN 3000 PUMP ACCESSORIES: 1) REPLACE 3 MM-BEVELED TUOHY NEEDLE WITH A 4 MM-BEVELED TUOHY NEEDLE; 2) REMOVE A RULER; 3) REPLACE REMAINING RULER WITH A NEW RULER; 4) REDUCE AERATION TIME FOR CODMAN 3000 PUMP ACCESSORIES; 5) NEW PACKAGING DESIGN; 6) NEW PACKAGING MATERIALS; 7) UPDATE LABELING TO REFLECT COMPONENT CHANGES; AND 8) CLARIFY ADDITIONAL NON-PYROGENIC COMPONENTS AND PROCEDURAL STEPS.
Current openFDA PMA Record#
- Device
- CODMAN 3000 IMPLANTABLE INFUSION PUMP
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S023
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2007-11-26
- Decision code
- APPR
- Date received
- 2007-10-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT AND TO THE CODMAN 3000 PUMP ACCESSORIES: 1) REPLACE 3 MM-BEVELED TUOHY NEEDLE WITH A 4 MM-BEVELED TUOHY NEEDLE; 2) REMOVE A RULER; 3) REPLACE REMAINING RULER WITH A NEW RULER; 4) REDUCE AERATION TIME FOR CODMAN 3000 PUMP ACCESSORIES; 5) NEW PACKAGING DESIGN; 6) NEW PACKAGING MATERIALS; 7) UPDATE LABELING TO REFLECT COMPONENT CHANGES; AND 8) CLARIFY ADDITIONAL NON-PYROGENIC COMPONENTS AND PROCEDURAL STEPS.