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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 MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY)
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
MEDTRONIC Inc.
8200 coral sea street
ms mvs11
mounds view, MN 55112
PMA NumberP980050
Supplement NumberS006
Date Received06/27/2001
Decision Date08/29/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE POST-APPROVAL PROTOCOL FOR CONTINUED FOLLOW-UP OF THE PATIENTS WHO RECEIVED THE MODEL 7250 FOR THE AF ONLY INDICATION.
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