Cardiac Designs, Inc. - June 29, 2016
Issue Date
Jun 29, 2016
Region
Southwest
Category
Device
$117.00
Contact Name
Robert D. Jordan
Contact Title
CEO & President
Address 1
25510 Interstate 45 North
Address 2
Ste. 202
City
Spring
State
TX
Zip/Postal Code
77386
Country
United States
Inspection Range
Jun 27, 2016 - Jun 29, 2016
Pages
1
First Observation
Procedures for design validation have not been adequately established.
Investigator(s): Leighton K. Ngai