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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMICRONY SR+ MODEL 2425T PULSE GENERATOR
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Nameimplantable pacemaker pulse generator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP970013
Date Received01/03/1997
Decision Date12/21/2000
Product Code
LWO[ Registered Establishments with LWO ]
Docket Number 01M-0013
Notice Date 01/16/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the microny(tm) sr+ model 2425t single chamber rate adaptive pulse generator, which is programmed with the aps ii programmer with modle 3204a software, the apsu programmer, and the model 3500/3510 programmer with model 3304 software. The deivce is indicated for the following: 1) accepted patient conditions warranting chronic cardiac pacing which include: sick sinus syndrome; chronic, symptomatic second- and third-degree av block; recurrent adams-stokes syndrome; and symtomatic bilateral bundle branch block when tachy-arrhythmia and other causes have been ruled out. 2) atrial pacing in patients with sinus node dysfunction and normal av and intraventricular conduction systems. 3) ventricular pacing in patients with significant bradycardia and: normal sinus rhythm with only rare episodes of av block or sinus arrest requiring short periods of pacing support, chronic atrial fibrillation, and severe physical disability. 4) rate-modulated pacing in patients who would benefit from increased pacing rates concurrent with physical activity.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
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S044 S045 S047 S048 S049 S051 
S052 S056 
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