FDA.reportPublic FDA data

INTERA ONCOLOGY

Matched from indexed company URL: 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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850014110024INTERA - Non-coring (Huber) needle for use with Intera 3000 Hepatic Artery Infusion Pump, Straight, 22 Gauge, 1.5 inch800-909-4815orders@interaoncology.com
00850014110048INTERA - "Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 1 3/8"" (3.5cm)"800-660-2660orders@interaoncology.com
00850014110055INTERA - "Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 2"" (5 cm)"800-660-2660orders@interaoncology.com
00850014110079INTERA - Refill Kit - Intera 3000800-909-4815interaoncology-us@healthlinkeurope.com
00850014110079INTERA - Refill Kit - Intera 3000800-909-4815orders@interaoncology.com

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#

Intera 3000 Hepatic Artery Infusion Pump

2022-09-29

Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS083 Date Received08/30/2022 Decision Date09/29/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process...

Intera 3000 Hepatic Artery Infusion Pump

2022-06-22

Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS081 Date Received05/27/2022 Decision Date06/22/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Re...

Intera 3000 Hepatic Artery Infusion Pump

2022-05-20

Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS080 Date Received04/26/2022 Decision Date05/20/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process...

PMN#

GUDID#