FDA.reportPublic FDA data

PMA P890055S073

Device
3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories
Applicant
Intera Oncology
PMA number
P890055
Supplement
S073
Product code
LKK
Decision date
2020-02-07
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for a manufacturing site located at Intera Oncology, Inc., 65 William Street, Suite 200, Wellesley, Massachusetts, to conduct quality system activities.

Current openFDA PMA Record#

Device
3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories
Applicant
Intera Oncology
PMA number
P890055
Supplement
S073
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-02-07
Decision code
APPR
Date received
2020-01-09
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Intera Oncology, Inc., 65 William Street, Suite 200, Wellesley, Massachusetts, to conduct quality system activities.