American Medical Systems Innovation Center - April 3, 2015
Issue Date
Apr 03, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Ginger S. Glaser
Contact Title
Vice President Global Regulatory Affairs
Address 1
3070 Orchard Dr.
City
San Jose
State
CA
Zip/Postal Code
95134-2011
Country
United States
Inspection Range
Mar 30, 2015 - Apr 03, 2015
Pages
3
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): James D. Hildreth