HeartWare, Inc. - May 4, 2016
Issue Date
May 04, 2016
Region
Southeast
Category
Device
$117.00
Contact Name
Andres S. Toledo
Contact Title
VP of Operations
Address 1
14400 N.W. 60th Ave.
City
Miami Lakes
State
FL
Zip/Postal Code
33014-2807
Country
United States
Inspection Range
Apr 04, 2016 - May 04, 2016
Pages
14
First Observation
Written MDR procedures have not been implemented.
Investigator(s): Dianiris C. Ayala and Sean T. Creighton