PMA Submissions Workshop

February 25 – 26, 2010 — The Westin Casuarina Hotel, Las Vegas, NV

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real world case studies. Topics include strategy development and evidence requirements, productive meetings with FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs.

Agenda

Click here to Download.

Speakers

Anthony Blank, Vice President Cardiovascular Regulatory Affairs, Boston Scientific
Laura Byrd, PMA Staff, ODE, FDA/CDRH
Michael Morton, Senior Director, Regulatory Affairs, Medtronic
Les Weinstein, Ombudsman, FDA/CDRH
Anastacia M. Bilek, Branch Chief, FDA/OPMD Division of Enforcement
Helen Lavin, Regulatory Affairs Manager, Boston Scientific

Hotel & Meeting Logistics

The Westin Casurina Hotel
160 East Flamingo Drive
Las Vegas, NV 89109
1-866-837-4215 (reservations)

A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $129.  Please make your reservations by contacting the hotel and identifying yourself as a member of the Advanced Medical Technology Association room block or by clicking here.  This rate will be available until February 5, 2010.  Room and rates are subject to availability after this date.  Please make your reservations early as the block will fill up quickly.

 

Registration Fees



Please contact skinchen@advamed.org for Group Discounts (Discount does not apply to AdvaMed Accel, Government, or Non-Profit Organizations)