Cardiogenesis, A Cryolife, Inc., Co. - May 23, 2013
Issue Date
May 23, 2013
Region
Southeast
Category
Device
$117.00
Contact Name
David M. Fronk
Contact Title
VP of Regulatory Affairs and Quality Assurance
Address 1
1655 Roberts Blvd. NW
City
Kennesaw
State
GA
Zip/Postal Code
30144
Country
United States
Inspection Range
May 14, 2013 - May 23, 2013
Pages
7
First Observation
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.
Investigator(s): Trang N. Cox, Leo J. Lagrotte, Abraham M. Maekele, and Miaja Umaedi