Asthmatx, Inc. - March 22, 2011
Issue Date
Mar 22, 2011
Region
Pacific
Category
Device
$117.00
Address 1
888 Ross Dr.
Address 2
Suite 100
City
Sunnyvale
State
CA
Zip/Postal Code
94089
Country
US
Inspection Range
Mar 02, 2011 - Mar 22, 2011
Pages
3
First Observation
The written MDR procedure does not include an internal system that provides for the timely and effective evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Mark A. Chen