Mainstay Medical Ltd. US, Inc. - Dec. 20, 2019
Issue Date
Dec 20, 2019
Region
Central
Category
Device
$117.00
Contact Name
Diane Burnside
Contact Title
Vice President Clinical Affairs
Address 1
6601 Shingle Creek Pkwy.
Address 2
Ste. 200
City
Minneapolis
State
MN
Zip/Postal Code
55430-1788
Country
United States
Inspection Range
Dec 05, 2019 - Dec 20, 2019
Pages
5
First Observation
Progress reports for a significant risk device study were not submitted at least yearly to all
reviewing IRBs.
Investigator(s): Nicole C. Victoria