Worldwide: USA including states of AL,AR,AZ,CA,CO, FL,GA, IA,IL, IN,KS,KY,LA, MA, MD, ME,MI, MN, MO,NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI and to the following countries: Austria, Canada, France, Netherlands, Singapore, Switzerland, and The United Kingdom
Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. || Product is manufactured and distributed by Thoratec Corporation, || Pleasant, CA. || The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to cardiac transplantation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital.
Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)
Descripción del producto
Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United States. || The component is used in the stabilization of constructs in the BacFix and InCompass spinal fixation systems. It is used within a temporary construct that assists normal healing and is not intended to replace normal body structures.