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Review Period Set for Medtronic Pacemakers

05/25/2007

Federal Register Notice: FDA has determined the regulatory review period for Medtronic Inc.’s KDR 401 and 403 pacemakers is 716 days for extending a patent which claims the medical devices. The pacemakers are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity and/or minute ventilation. They are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. To view this notice, click here.

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