PMA P890055S068
- Device
- Codman 3000 and Medstream Implantable Infusion Pumps
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S068
- Product code
- LKK
- Decision date
- 2017-07-05
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Implementation of a new sterilization chamber control system at the sterilization facility to replace the current system.
Current openFDA PMA Record#
- Device
- Codman 3000 and Medstream Implantable Infusion Pumps
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S068
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2017-07-05
- Decision code
- OK30
- Date received
- 2017-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new sterilization chamber control system at the sterilization facility to replace the current system.