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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 NameMEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namearrhythmia management devices
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS020
Date Received08/25/1995
Decision Date12/14/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for med rel, road 909, km. 0. 4, barrio mariana, humacao, puerto rico 00661 to manufacture the models 7219b, 7219e, and 7202e.
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