Corindus, Inc. - Oct. 4, 2016
Issue Date
Oct 04, 2016
Region
Northeast
Category
Device
$117.00
Contact Name
Douglas R. Teany
Contact Title
Senior VP R&D and Operations
Address 1
309 Waverly Rd.
Address 2
Ste. 105
City
Waltham
State
MA
Zip/Postal Code
02452
Country
United States
Inspection Range
Sep 27, 2016 - Oct 04, 2016
Pages
1
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 has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Nabil Nakhoul