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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP990001
Supplement NumberS014
Date Received02/20/2003
Decision Date09/16/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to rate response features, addition of telemetry b, and other diagnostic enhancements. The device, as modified, will be marketed under the trade name medtronic/vitatron da+ c-series implantable generators and is indicated as follows: 1) dual chamber pacing is indicated if av synchrony needs to be restored in order to optimize cardiac output. For example, patients with symptomatic second or third degree av block. 2) dual chamber rate responsive pacing modes are of specific benefit to patients with chronotropic incompetence of the sinus node. 3) rate responsive modes can help patients who have a requirement for anincrease in pacing rate in response to physical activity. 4) single chamber ventricular pacing can help patients with permanent atrialtachyarrhythmias, including atrial fibrillation and flutter. 5) single chamber atrial pacing can help patients with symptomatic bradyarrhythmiasand normal av conduction.