I2s Micro Implantable Systems, LLC - May 14, 2010
Issue Date
May 14, 2010
Region
Southwest
Category
Device
$117.00
Address 1
391 Chipeta Way
Address 2
Suite G
City
Salt Lake City
State
UT
Zip/Postal Code
84108-1264
Country
US
Inspection Range
May 11, 2010 - May 14, 2010
Pages
3
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Bryan J. Love