Intera Oncology

FDA Filings

This page includes the latest FDA filings for Intera Oncology. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015537318
• FEI Number: 3015537318
• Name: INTERA ONCOLOGY
• Owner & Operator: Intera Oncology
• Contact Address: 65 William Street Suite 200; Wellesley MA 02481 US
• Official Correspondent:
  • Michael Gaisford
  • x-781-4895724-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 65 William Street Suite 200; Wellesley, MA 02481 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMA P890055S079 Intera Oncology	lntera 3000 Hepatic Artery Infusion Pump	2022-01-27
PMA P890055S078 Intera Oncology	Intera 3000 Hepatic Artery Infusion Pump	2021-12-06
PMA P890055S077 Intera Oncology	Intera 3000 Hepatic Artery Infusion Pump accessories	2021-04-13
PMA P890055S076 Intera Oncology	Codman OR Prep Kits	2020-12-16
PMN P890055 | LKK INTERA ONCOLOGY	Accessories for Model 3000 Series Implantable Infusion Pump	2020-03-05
PMN P890055 | LKK INTERA ONCOLOGY	Accessories for Medstream Implantable Infusion Pump	2020-03-05
PMN P800036 | LKK INTERA ONCOLOGY	Accessories for Model 400 Implantable Infusion Pump	2020-03-05
PMA P890055S073 Intera Oncology	3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories	2020-02-07
PMA P800036S041 Intera Oncology	INFUSAID Implantable Infusion Pump and Accessories	2020-02-07
PMA P800036S040 Intera Oncology	Model 400 Implantable Infusion Pump	2017-07-05
PMA P800036S039 Intera Oncology	Model 400 Implantable Infusion Pump	2016-08-29
PMA P800036S038 Intera Oncology	INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP	2014-08-01
PMA P800036S037 Intera Oncology	IMPLANTABLE DRUG DELIVERY SYSTEM	2010-12-22
PMA P800036S036 Intera Oncology	INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP	2006-06-23
PMA P800036S035 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP	1997-12-19
PMA P800036S034 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP	1997-12-19
PMA P800036S032 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP	1996-12-30
PMA P800036S031 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP	1996-12-23
PMA P800036S015 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1995-09-20
PMA P800036S030 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400	1995-08-14
PMA P800036S029 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400	1993-06-17
PMA P800036S025 Intera Oncology	INFUSAID REFILL KIT	1990-10-19
PMA P800036S024 Intera Oncology	INFUSAID REFILL KIT	1990-10-19
PMA P800036S021 Intera Oncology	NFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1989-10-18
PMA P800036S019 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1989-08-10
PMA P800036S018 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1989-08-08
PMA P800036S013 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1988-11-04
PMA P800036S016 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1988-03-22
PMA P800036S008 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1986-08-06
PMA P800036S011 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1986-06-19
PMA P800036S012 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1985-11-12
PMA P800036S009 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1985-10-30
PMA P800036S006 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1985-10-30
PMA P800036S007 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1985-09-30
PMA P800036S005 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1984-06-04
PMA P800036S004 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1983-07-05
PMA P800036S003 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1983-06-02
PMA P800036S002 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1983-02-25
PMA P800036S001 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1982-06-23
PMA P800036 Intera Oncology	INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4	1982-03-03

Similar & Related FDA Registered Companies

• Intera Oncology, Inc.
• 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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• 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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No