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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 NameMODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedf-1 adaptor/extender
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS022
Date Received05/31/2001
Decision Date06/15/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 6726 df-1 y-adaptor/extender kit. The device is indicated to adapt two df-1 lead connectors to a single df-1 compatible connector port and/or will extend the length of a df-1 lead connector. The model 6726 has application for patients in which idc systems are indicated.
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