Miramar Labs, Inc. - Aug. 17, 2015
Issue Date
Aug 17, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Kathryn F. O'Shaughnessy
Contact Title
Vice President, Clinical, Regulatory and QA
Address 1
2790 Walsh Ave.
City
Santa Clara
State
CA
Zip/Postal Code
95091
Country
United States
Inspection Range
Jul 22, 2015 - Aug 17, 2015
Pages
4
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): Alla Dubrovsky