Penumbra - Aug. 24, 2010
Issue Date
Aug 24, 2010
Region
Pacific
Category
Device
$117.00
Address 1
1351 Harbor Bay Pkwy.
City
Alameda
State
CA
Zip/Postal Code
94502-6541
Country
US
Inspection Range
Aug 20, 2010 - Aug 24, 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 may have caused or contributed to a death or serious injury.
Investigator(s): Linda S. Shook