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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 NameBYREL PROGRAMABLE PACEMAKER
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameprogramable a-v sequential cardiac pacemaker
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP780009
Date Received11/20/1978
Decision Date03/27/1979
Withdrawal Date 04/14/2008
Product Code
LWP[ Registered Establishments with LWP ]
Notice Date 08/03/1979
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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