PMA P890055S069
- Device
- Codman 3000 Series Constant Flow Implantable infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S069
- Product code
- LKK
- Decision date
- 2018-07-06
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for a updated MRI labeling for the Codman 3000 pump.
Current openFDA PMA Record#
- Device
- Codman 3000 Series Constant Flow Implantable infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S069
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2018-07-06
- Decision code
- APPR
- Date received
- 2017-08-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a updated MRI labeling for the Codman 3000 pump.