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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.
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namepulse-generator, single chamber, sensor driven, implantable
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S047 
S048 S049 S050 S051 S052 S054 S055 S056 S057 
S058 S059 S060 S063 S064 S065 S066 S067 S069