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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.
 
Trade NameAUTIMA/AURORA CARDIAC PACING SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantTELECTRONICS, INC.
PMA NumberP820018
Supplement NumberS063
Date Received07/05/1994
Decision Date07/23/1996
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in sterilization contractor. The proposed sterilization contractor is:griffith micro science, inc. , 2973 olympic industrial drive, smyrna, ga 30080-7322.
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