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following the introduction of its Palmaz-Schatz stent in 1994. J&J subsequently licensed the know-how to a few of its rivals, together with Medtronic Inc. . Other producers challenged the patent, and litigation stays in course of. FDA Cincinnati District compliance officer Lawrence E. Boyd says medical system firms that haven’t yet carried out something to comply with new high quality system design control rules ought to develop procedures for implementing the laws in the event that they wish to keep away from a warning letter. “They should have a plan to explain

 

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