St. Jude Medical, Inc. -- Moody's says St. Jude Medical's warning letter on cardiac rhythm management plant credit negative; ratings unaffected

New York, January 15, 2013 -- Moody's Investors Service said that last Friday, St. Jude Medical, Inc. (Baa1 stable) filed a form 8-K stating that its cardiac rhythm management (CRM) division received an FDA warning letter for its Sylmar, CA facility related to observations that certain quality system regulation practices did not adhere to good manufacturing practice standards. This is credit negative because the FDA will not approve new Class III (highly regulated) devices or provide export certificates to foreign governments for products made at Sylmar until the issues that gave rise to the warning letter are resolved to the FDA's satisfaction.

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