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St. Jude Photon ICD PMA Submission Expected By Mid-Year

This article was originally published in The Gray Sheet

Executive Summary

St. Jude Medical says it expects to file a premarket approval application with FDA for the Photon DR dual-chamber implantable cardioverter defibrillator by mid-year.

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St. Jude Photon DR

Dual-chamber, rate responsive, implantable cardioverter defibrillator premarket approval application is submitted to FDA, the firm reports June 14. The 46 cc tachycardia device offers 37 J of stored energy and incorporates Affinity pacemaker technology for treatment of bradycardia as well (1"The Gray Sheet" Feb. 14, p. 12). Approval of the device, "the world's thinnest dual-chamber ICD" at 12.7 mm, is anticipated later this year. St. Jude is counting on the Photon to wrest ICD market share from market leaders Medtronic and Guidant

St. Jude Photon DR

Dual-chamber, rate responsive, implantable cardioverter defibrillator premarket approval application is submitted to FDA, the firm reports June 14. The 46 cc tachycardia device offers 37 J of stored energy and incorporates Affinity pacemaker technology for treatment of bradycardia as well (1"The Gray Sheet" Feb. 14, p. 12). Approval of the device, "the world's thinnest dual-chamber ICD" at 12.7 mm, is anticipated later this year. St. Jude is counting on the Photon to wrest ICD market share from market leaders Medtronic and Guidant

Guidant Prizm Defibrillator Launches Jan. 31; Fourth Quarter Sales Up 16%

Shipments of Guidant's Ventak Prizm dual-chamber automatic implantable cardioverter defibrillator are anticipated to begin Jan. 31 following FDA approval via premarket approval application supplement, announced Jan. 24. A list price for the device is still being finalized.

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