Integra Neurosciences PR, Inc. - October 22, 2009
Issue Date
Oct 22, 2009
Region
Southeast
Category
Device
$117.00
Address 1
Carr 402 Norte
Address 2
Room 1.2
City
Anasco
State
PR
Zip/Postal Code
610
Country
US
Inspection Range
Oct 07, 2009 - Oct 22, 2009
Pages
4
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): Noreen Muniz