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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 Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Supplement NumberS277
Date Received06/29/2012
Decision Date01/15/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00433654
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of an mr-conditional system permitting implanted patients to undergo mri scans provided specified conditions are met. The devices, as modified, make up the advisa dr mri surescan system and will be marketed under the trade names advisa dr mri a2dr01 implantable pulse generator with software model 9995, carelink monitor model 2490g, cardiosight reader model 2020a and ddma model 2491. The advisa dr mri surescan system is indicated for the following: 1) rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity; and2) accepted patient conditions warranting chronic cardiac pacing include:a) symptomatic paroxysmal or permanent second-or third-degree a vblock; b) symptomatic bilateral bundle branch block; c) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated a v conduction disorders d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and e) vasovagal syndromes or hypersensitive carotid sinus syndromes. The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of av synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony, which include:1) various degrees of av block to maintain the atrial contribution tocardiac output; and 2) vvi intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythmantitachycardia pacing (a tp) is indicated for termination of atrialtachyarrhythmias in bradycardia patients with one or more of the above pacing indications.
Post-Approval StudyShow Report Schedule and Study Progress