PMA P800036S040
- Device
- Model 400 Implantable Infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P800036
- Supplement
- S040
- Product code
- LKK
- Decision date
- 2017-07-05
- 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
- Model 400 Implantable Infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P800036
- Supplement
- S040
- 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.