Saphena Medical, Inc. - May 24, 2018
Issue Date
May 24, 2018
Region
Northeast
Category
Device
$117.00
Contact Name
Mark J. Orphanos
Contact Title
Chief Operating Officer
Address 1
375 West St.
City
West Bridgewater
State
MA
Zip/Postal Code
02379-1014
Country
United States
Inspection Range
May 23, 2018 - May 24, 2018
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 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