Miramar Labs, Inc. - Aug. 1, 2016
Issue Date
Aug 01, 2016
Region
Pacific
Category
Device
$117.00
Contact Name
Robert M. Klein
Contact Title
President & CEO
Address 1
2790 Walsh Ave.
City
Santa Clara
State
CA
Zip/Postal Code
95051-0963
Country
United States
Inspection Range
Jul 25, 2016 - Aug 01, 2016
Pages
2
First Observation
The written MDR Procedure does not include an internal system which provides for the timely and
effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Mary R. Hole