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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.
 
DeviceMEDTRONIC(R) 7000 VERSATRAX(R) PULSE GENERATOR
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 NumberP820003
Supplement NumberS060
Date Received11/05/1991
Decision Date12/18/1991
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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