Spineology - June 30, 2010
Issue Date
Jun 30, 2010
Region
Central
Category
Device
$117.00
Address 1
7800 3rd. St. North
Address 2
Suite 600
City
St. Paul
State
MN
Zip/Postal Code
55128-5451
Country
US
Inspection Range
Jun 09, 2010 - Jun 30, 2010
Pages
2
First Observation
For an investigational study, proper monitoring was not ensured, IRB review and approval were not ensured, reviewing IRBs were not promptly informed of significant new information about an investigation, and FDA was not promptly informed of significant new information about an investigation.
Investigator(s): Sharon L. Matson