PMA

9
Dec

FDA PMA and BLA for APLIGRAF and GINTUIT

Class III Medical Device and Biologics License Application (BLA) Class III Medical Device APLIGRAF: P950032 Expedited processing eras authorized on May 30 1995 based on the potential of Apligraf to provide a clinically important advance over existing alternatives in the treatment of chronic venous insufficiency ulcers. Intended Use/Indications Apligraf is indicated for use with standard therapeutic compression for the treatment of non infected partial and full

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9
Dec

Would Care Wound and Burn Dressing PMAs

Wound and Burn Dressing Summary of Regulatory Approval Pathways Class III Device PMA Combination Product Product Code:  MGR PMA Devices 1). Integra Dermal Regeneration Template: P900033 (a device to treat the skin of people with severe burns) INTEGRA® Dermal Regeneration Template is a device to treat the skin of people with severe burns. FDA has recently expanded the approved use of this

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6
Aug

FDA Approves a Weight Loss System

ORBERA Intragastric Balloon System Approval Date: August 5, 2015 Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008a.pdf Product Code: LTI Device: Implant, Intragastric For Morbid Obesity TPLC-LTI (learn common problems from devices under product code “LTI”) The ORBERA Intragastric Balloon System is a weight-loss system that uses a gastric balloon that occupies space in the stomach. The balloon is placed into the stomach through the mouth,

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27
Mar

In-Person 2-Day Seminar for 510ks and PMAs

How to Format Succinct and Comprehensive 510(k)s and PMAs 2 Day Seminar, April 9-10, 2015 Research Triangle, NC [button url=”https://www.globalcomplianceseminar.com/event/how-to-format-succinct-and-comprehensive-510ks-and-pmas/?instance_id=15132″ target=”blank” style=”3d” background=”#c91119″ size=”10″ wide=”yes” center=”yes”]Recorded version is available here[/button] Overview This seminar will discuss the 510(k) and PMA submissions and will walk you through how to format a succinct and comprehensive 510(k) and premarket approval (PMA) application to increase

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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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18
Nov

Medical Device for Epilepsy Approved

Medical Device for Epilepsy Approved | NeuroPace RNS System By Regulatory Doctor; LinkedIn; Google Plus; Twitter 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. [animate duration=”7″ delay=”3″][youtube url=”http://www.youtube.com/watch?v=YQeGq_L_QO8&feature=youtu.be”][/animate] The RNS Stimulator consists

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13
Nov

FDA Advisory Panel Unanimously Voted for the Approval of Nuclear Hybrid L24 Implant System

FDA Advisory Panel Unanimously Voted for the Approval of Nuclear Hybrid L24 Implant System By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 26, 2014 FDA PMA | P130016 | Nucleur Hybrid L24 Implant System EAR, NOSE AND THROAT (ENT) DEVICES PANEL of the  MEDICAL DEVICES ADVISORY COMMITTEE Nucleus® Hybrid™ L24 Implant System | Cochlear Americas On November 8,

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8
Nov

FDA PMA Cardiac Resynchronization Therapy Pacemaker CRT-P

FDA PMA for Cardiac Resynchronization Therapy Pacemaker (CRT-P) By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) Device: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) Definition These devices are indicated for patients who have moderate to severe heart failure.These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a

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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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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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