Brief: Saluda Medical Initiates Voluntary Field Action For Certain Evoke® System Devices
Wed 02:01
BRIEF-Saluda Medical Initiates Voluntary Field Action For Certain Evoke® System Devices Oct 21 (Reuters) - Saluda Medical, Inc SLD.AX:
VOLUNTARY FIELD ACTION FOR CERTAIN EVOKE® SYSTEM DEVICES
ACTION FOLLOWING IDENTIFICATION OF A LOW-INCIDENCE ISSUE RELATED TO A THIRD-PARTY MANUFACTURING PROCESS CHANGE.
DEVICES MANUFACTURED AND DISTRIBUTED FOLLOWING IMPLEMENTATION OF CORRECTIVE ACTION ARE UNAFFECTED BY ISSUE
DOES NOT EXPECT ACTION TO DISRUPT PRODUCT SUPPLY OR ITS ABILITY TO MEET CUSTOMER DEMAND
ALSO DOES NOT CURRENTLY EXPECT ACTION TO HAVE A MATERIAL EFFECT ON ITS OPERATIONS
ENGAGING WITH U.S. FDA AND OTHER APPLICABLE REGULATORY AUTHORITIES REGARDING ACTION AND ITS CLASSIFICATION UNDER FIELD ACTION
Further company coverage: SLD.AX
((Reuters.Briefs@thomsonreuters.com;))
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