FDA.reportPublic FDA data

INTERA ONCOLOGY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155373183015537318INTERA ONCOLOGY1N2026-01-01180 Wells Avenue Suite 300A Newton MA US 02459
30155373183015537318INTERA ONCOLOGY1N2020-04-2565 William Street Suite 200 Wellesley MA US 02481

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3405071338635668P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMLKK1996-03-11
2392291666124646P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMLKK1996-03-11
2392291474225635P800036INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4LKK1982-03-03
3405071722198476K213823Intera Refill KitPTI2022-03-16
3405071882888647K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitPTI2021-10-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PTI22022-03-16
LKK21996-03-11
LKK 11982-03-03

PMA#