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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.
 
DeviceLEGEND II MODELS 8424,8426,8427 AND 8430 PULSE G.
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namepulse-generator, single chamber, sensor driven, implantable
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
mounds view, MN 55112
PMA NumberP850051
Supplement NumberS032
Date Received05/30/1991
Decision Date11/25/1991
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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