St. Jude Medical (CardioMEMS) - June 26, 2015
Issue Date
Jul 06, 2015
Region
Southeast
Category
Device
$117.00
Contact Name
Jeff H. Kim
Contact Title
Director of Quality Assurance Engineering
Address 1
387 Technology Cir. NW
Address 2
Ste. 500
City
Atlanta
State
GA
Zip/Postal Code
30313- 2424
Country
United States
Inspection Range
Jun 08, 2015 - Jun 26, 2015
Pages
8
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): Claudette D. Brooks and Miaja Umaedi