Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3002095335.
Observations5
Issue DateJuly 11, 2015
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections10
Establishment Details
Firm
Boston Scientific Corporation
Location
Maple Grove, Minnesota, United States
FEI Number
3002095335
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
July 11, 2015
Country
United States
Inspection History, 2010 to 2025
NAI7
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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