www.fdanews.com/articles/165177-fda-warns-cook-over-uncleared-design-changes
FDA Warns Cook Over Uncleared Design Changes
June 13, 2014
Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval.
The GMP Letter
The GMP Letter