Sean Snow - Carpinteria CA, US Mark O'Donnell - Goleta CA, US Amy Tezel - Goleta CA, US Marcos Borrell - Goleta CA, US
Assignee:
ALLERGAN, INC. - Irvine CA
International Classification:
G01M 3/04
US Classification:
702 51
Abstract:
Generally described herein are devices, methods and systems related to detecting a leak present in a gastric banding system for the treatment of obesity. For example, a leak detector may include a syringe, a leak sensing unit and a needle, and may measure a pressure decay within a gastric banding system after the needle penetrates the patient's skin and is inserted into an access port connected to the gastric band of the gastric banding system. The pressure decay may be interpreted to determine if a leak is present in the gastric banding system.
Name / Title
Company / Classification
Phones & Addresses
Amy Tezel Director, Managing
AMY TEZEL REGULATORY CONSULTING, LLC
6801 Saucon Vly Dr, Fort Worth, TX 76132 6801 Sancon Vly Dr, Fort Worth, TX 76132
Bvi Medical
Vice President, Clinical and Regulatory Affairs
Alcon, A Novartis Company Feb 2016 - Oct 2016
Global Head, Intraocular Implants - Regulatory Affairs
Alcon, A Novartis Company Feb 2016 - Oct 2016
Vice President, Global Regulatory Affairs - Surgical Franchise
3D Communications, Llc Aug 2014 - Feb 2016
Scientific Executive
Alcon, A Novartis Company Oct 2013 - Jul 2014
Director, Global Regulatory Affairs
Education:
Uc Santa Barbara 1999 - 2005
Doctorates, Doctor of Philosophy, Chemical Engineering, Philosophy
University of Washington 1995 - 1999
Bachelors, Bachelor of Science, Chemical Engineering
Skills:
Regulatory Strategy Regulatory Submissions Fda Medical Devices Strategy Regulatory Affairs Gmp Pma Capa Validation Iso 13485 Change Control Pharmaceutical Industry V&V 21 Cfr Part 11 Iso 14971 Sop Design Control Biopharmaceuticals Regulatory Requirements Ectd Clinical Development Fda Gmp Aseptic Processing Technology Transfer Clinical Trials Gcp Glp Quality Assurance Quality System Ind Gxp Biotechnology Leadership U.s. Food and Drug Administration