St. Jude Medical Puerto Rico, LLC - June 24, 2010
Issue Date
Jun 24, 2010
Region
Southeast
Category
Device
$117.00
Address 1
Lot A Interior - Carr #2 Km #67.5
Address 2
Santana Indl. Park, Sector Los Pinos
City
Arecibo
Zip/Postal Code
00613-6025
Country
PR
Inspection Range
May 10, 2010 - Jun 24, 2010
Pages
9
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggest that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Rafael Gonzalez and Marilyn Santiago