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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 NameMEDA-MV PACING SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Namepacemaker
Regulation Number870.3610
ApplicantTELECTRONICS, INC.
PMA NumberP880038
Supplement NumberS028
Date Received07/29/1994
Decision Date07/23/1996
Product Code
DXY[ Registered Establishments with DXY ]
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 microscience, inc. , 2973 olympic industrial drive, smyrna, georgia 30080-7322.
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