St. Jude Medical Implantable Electronic Systems Division - April 11, 2014
Issue Date
Apr 11, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Dr. Eric S. Fain, M.D.
Contact Title
Group President
Address 1
15900 Valley View Ct.
City
Sylmar
State
CA
Zip/Postal Code
91342-3577
Country
United States
Inspection Range
Apr 07, 2014 - Apr 11, 2014
Pages
2
First Observation
Procedures for design verification have not been adequately established.
Investigator(s): Juanita Banuelos and Jessica E. Paulsen