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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBYREL PROGRAMABLE PACEMAKER
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP780009
Supplement NumberS001
Date Received06/12/1981
Decision Date07/21/1981
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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