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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY)
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cdardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
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 protocol or modification to a protocol
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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