St. Jude Tempo pacemaker shipments under way the week of Jan. 12 following approval of Sylmar facility.
This article was originally published in The Gray Sheet
Executive Summary
ST. JUDE TEMPO PACEMAKER SHIPMENTS UNDER WAY THE WEEK OF JAN. 12 following a build-up of inventory at the company's Pacesetter unit manufacturing facility in Sylmar, California. The firm received FDA approval for the Tempo, which incorporates "fifth generation" Minute Ventilation sensor technology, via premarket approval application supplement in August 1997, but decided to defer production until receiving an additional PMA supplement approval to manufacture at the Sylmar site Oct. 16. The systems will cost up to an average of $6,000, depending on model and purchase volume, St. Jude states.
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