SynCardia Systems, LLC - Aug. 18, 2017
Issue Date
Aug 18, 2017
Region
Pacific
Category
Device
$117.00
Contact Name
Brian I. Brogie
Contact Title
Vice President, Manufacturing & Facilities
Address 1
1992 E. Silverlake Rd.
City
Tucson
State
AZ
Zip/Postal Code
85713-3865
Country
United States
Inspection Range
Aug 14, 2017 - Aug 18, 2017
Pages
2
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): Jude C. Dike