PMA P890055S078

Device
Intera 3000 Hepatic Artery Infusion Pump
Applicant
Intera Oncology
PMA number
P890055
Supplement
S078
Product code
LKK
Decision date
2021-12-06
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Change in the supplier of components of the Intera 3000 pump.

Current openFDA PMA Record#

Device
Intera 3000 Hepatic Artery Infusion Pump
Applicant
Intera Oncology
PMA number
P890055
Supplement
S078
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2021-12-06
Decision code
OK30
Date received
2021-11-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the supplier of components of the Intera 3000 pump.