Tag: PMA

25
Sep

Listen to What Patients Have to Say about Contraceptive Device Essure

The United States Food and Drug Administration (FDA) touts about “patient voice” or “patient preference” of  valuing the experience and perspectives of patients with devices as reflected in recent guidance entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.” FDA believes that patients can and should bring their own

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24
Nov

Ablation Catheter Approved to Treat Arrhythmia

FDA PMA Approval TactiCath Quartz Contact Force Ablation Catheter and TactiSys Quartz Equipment – P130026 FDA Approval Letter for P130026, Dated October 24, 2014 Summary of Safety and Effectiveness Data (SSED) and Labeling What is it? The TactiCath Quartz Contact Force Ablation Catheter (TactiCath) is a flexible catheter used to treat a certain kind of abnormal heart rhythm (arrhythmia) called paroxysmal

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15
Feb

New Class III Device Approval for An Artificial Aortic Valve

A New Class III Device Approval for An Artificial Aortic Valve: CoreValve System – P130021 By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 21, 2014 An artificial aortic valve (often referred to as the CoreValve) implanted through a delivery catheter Product Name: Medtronic CoreValve System Manufacturer: Medtronic CoreValve LLC Approval Date: January 17, 2014 Approval Letter What is it?  The main

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18
Nov

Medical Device for Epilepsy

Medical Device for Epilepsy NeuroPace RNS System FDA PMA P100026 NeuroPace RNS® System for Epilepsy On November 14, 2013, the US FDA approved the NeuroPace RNS system, a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications. The RNS Stimulator consists of a small neurostimulator implanted within the skull under the

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7
Nov

FDA Meeting PMA P130016 Nucleur Hybrid L24 Implant System

FDA PMA P130016 Nucleur Hybrid L24 Implant System By Dr. David Lim, Ph.D., RAC, ASQ-CQA EAR, NOSE AND THROAT (ENT) DEVICES PANEL of the  MEDICAL DEVICES ADVISORY COMMITTEE Nucleus® Hybrid™ L24 Implant System | Cochlear Americas On November 8, 2013, FDA’s ENT Devices Panel will convene and discuss PMA 130016. The relevant FDA meeting materials are shown below. Agenda http://regulatorydoctor.com/wp-content/uploads/2013/11/ENT-Meeting-Day-Agenda-FINAL.pdf Roster

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6
Nov

Preamendment Class III Devices | Exempted Class I and Class II Devices

Preamendment Class III Devices | Exempted Class I and Class II Devices By Dr. David Lim, Ph.D., RAC, ASQ-CQA (Regulatory Doctor; LinkedIn; Google Plus; Twitter) The April 9, 2009, Order applies to all manufacturers of the twenty-five (25) device types listed below. Learn more here. DEVICE TYPE CLASSIFICATION REGULATION (21 CFR XXX.XXX) CORRESPONDING PRODUCT CODE(s) Membrane lung for long-term pulmonary support 868.5610 BYS Intra-aortic

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28
Oct

FDA Panel Voted for the Approval of ReSure Sealant

FDA Panel Voted for the Approval of ReSure Sealant  By Dr. David Lim, Ph.D., RAC, ASQ-CQA (Regulatory Doctor LinkedIn Google Plus Twitter Facebook Tumblr) and Updated on December 29, 2014 P130004 | ReSure® Sealant |Ocular Therapeutix, Inc. September 19, 2013 Proposed Indication for Use (IFU) for the ReSure Sealant It is indicated for the intraoperative management of clear corneal incisions with a wound leak demonstrated

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10
Oct

FDA Advisory Panel Supports FDA Approval of Wireless Heart Failure Monitoring Device

FDA Advisory Panel Supports FDA Approval of Wireless Heart Failure Monitoring Device October 9, 2013 | CardioMEMS Champion HF Monitoring System PMA Amendment | P100045 FDA and CardioMEMS Panel Package Materials October 8-9, 2013: Meeting Materials FDA Generated The FDA advisory committee discussed, made recommendations, and voted on information related to the premarket approval application regarding the expansion of indications supported by

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29
Sep

Artificial Heart Valve Approved for Patients with Inoperable Aortic Valve Stenosis

  Artificial Heart Valve Available for Patients with Inoperable Aortic Valve Stenosis FDA approval expands access to artificial heart valve for inoperable patients September 29, 2013 The U.S. Food and Drug Administration approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of

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10
Jul

LIVE Online Seminar | How to Draft a PMA Like a PRO