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St. Jude Medical's Profile MD

This article was originally published in The Gray Sheet

Executive Summary

Implantable cardioverter defibrillator gains FDA approval via premarket approval application supplement, announced Nov. 17. The single-lead, 32 joule system is the "world's smallest defibrillator" at 34 cc, the company says. St. Jude is gearing up production for a U.S. launch in early 1999 of the system, which will replace the larger 44 cc Angstrom MD ICD. The Profile MD will be comparably priced with the Angstrom MD in the low $20,000-range. A PMA supplement for the firm's Affinity pacing system, submitted last summer, is currently pending at FDA
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