FLOWONIX MEDICAL, INC.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• Prometra Programmable Infusion Pump System

  2022-04-28

  FLOWONIX MEDICAL, INC.500 International Drivesuite 200mt.olive, NJ 07828 PMA NumberP080012 Supplement NumberS072 Date Received03/30/2022 Decision Date04/28/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) S...

• Prometra Programmable Infusion Pump System

  2021-03-02

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2020-10-29

  FLOWONIX MEDICAL, INC.

• Prometra II Programmable Infusion Pump System

  2020-03-17

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2020-01-15

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28

  2019-10-22

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2019-09-23

  FLOWONIX MEDICAL, INC.

• Prometra II Programmable Infusuin Pump System

  2019-08-07

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2019-07-03

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2019-03-07

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2019-01-31

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2019-01-28

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2018-12-17

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2018-08-17

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump

  2017-12-19

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2017-09-11

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2017-08-21

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2017-07-21

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2017-06-29

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2017-06-07

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2017-05-31

  FLOWONIX MEDICAL, INC.

• PROMETRA PATIENT THERAPY CONTROLLER

  2017-03-31

  FLOWONIX MEDICAL, INC.

• Prometra Programmable Infusion Pump System

  2017-03-30

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM CLINICIAN PROGRAMMER

  2016-12-16

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

  2016-08-31

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2016-05-26

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2016-01-12

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE PUMP SYSTEM

  2015-12-28

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

  2015-11-24

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

  2015-09-01

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

  2015-07-31

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2015-07-29

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2015-04-08

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2015-02-12

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2015-02-10

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2014-12-18

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2014-05-22

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2014-02-04

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

  2013-07-02

  FLOWONIX MEDICAL, INC.

• PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

  2013-06-24

  FLOWONIX MEDICAL, INC.

54 records. Showing 1-40. Next

GUDID#

• Prometra Programmable Pump - Prometra II 40ml Programmable Pump

  Flowonix Medical, Inc.

  2020-06-05

• Prometra Programmable Pump - The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.

  Flowonix Medical, Inc.

  2014-09-24

• Prometra II Pump - The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.

  Flowonix Medical, Inc.

  2015-04-29

• Prometra Tunneler - The Tunneler is used for subcutaneous placement of the Intrathecal Catheter. It is a sterile, malleable stainless steel tunneler with a pointed tip to penetrate subcutaneous tissue and a threaded end for attachment to the Intrathecal Catheter.

  Flowonix Medical, Inc.

  2014-09-24

• Prometra Catheter Access Kit - The Catheter Access Kit is sterile and provides the components and instructions necessary to access the catheter access port of the Prometra Programmable Pump. The catheter access port is located on the periphery of the pump to allow for direct access to the catheter without interfering with the drug reservoir.

  Flowonix Medical, Inc.

  2014-09-24

• Prometra Refill Kit - The Refill Kit is sterile and provides the components and instructions necessary to access the pump reservoir to empty and fill the Prometra Programmable Pump. The drug chamber is refillable and is percutaneously accessed via the centrally-located access port using a 22-gauge non-coring needle.

  Flowonix Medical, Inc.

  2014-09-24

• Prometra Clinician Programmer Print Tool - 12840

  Flowonix Medical, Inc.

  2020-06-05

• Prometra Clinical Programmer - Prometra Clinician Prgrammer

  Flowonix Medical, Inc.

  2020-06-05

• Prometra Intrathecal Catheter - The Intrathecal Catheter is a sterile, single-piece, radiopaque, silicone catheter with a pre-inserted hydrophilic stiffening stylet that is used to assist in placing the catheter.

  Flowonix Medical, Inc.

  2014-09-24

• Prometra Catheter Revision Kit - The Catheter Revision Kit is a sterile kit designed to facilitate the replacement of a section of the intrathecal catheter. A replacement catheter segment is provided with a catheter connector (and sleeve) to allow this segment to be attached to the existing catheter.

  Flowonix Medical, Inc.

  2014-09-24

• Prometra Programmer - The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the Prometra pump.

  Flowonix Medical, Inc.

  2014-09-24

• Prometra Programmer - The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus).

  Flowonix Medical, Inc.

  2015-04-29

• Prometra Patient Therapy Controller - The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.

  Flowonix Medical, Inc.

  2015-08-24

• Prometra Physician Configuration Device - The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller.

  Flowonix Medical, Inc.

  2015-08-24