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St. Jude’s long-awaited entry into the implantable cardioverter defibrillator (ICD) market ended on June 30, when the firm learned that the FDA had approved its ICD devices after more than a month of delays.
Mentor received full European Union (E.U.) Class III CE Mark approval last week for its line of breast implant products, making it the second U.S. firm in a month to receive E.U. approval for silicone implants.