Sonablate Corp. - Aug. 2, 2022
Issue Date
Aug 02, 2022
Region
Southeast
Category
Device
$117.00
Contact Name
Karen E. Cornett
Contact Title
V.P. Clinical Operations
Address 1
10130 Perimeter Pkwy.
Address 2
Ste. 410
City
Charlotte
State
NC
Zip/Postal Code
28216-2447
Inspection Range
Jul 21, 2022 - Aug 02, 2022
Pages
6
First Observation
The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
Investigator(s): Gamal A. Norton