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FDA Import Refusal 799-3331871-9/11/1 — Bolton Medical Inc.

Bolton Medical Inc. — FEI 1000135961

The FDA refused shipment 799-3331871-9/11/1 from Bolton Medical Inc. (United States) on March 31, 2023. The refused product falls under Devices — SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT. Cited charges: 118,341

Refusal Details

Date
March 31, 2023
Country
United States
Product Category
Devices
Product Code
74MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Charges
118,341

Recent inspections

  • 1111697 (NAI Wed Nov 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103583 (NAI Mon Sep 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987958 (NAI Mon Sep 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844604 (NAI Fri Aug 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 775678 (VAI Tue Mar 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources