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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 NameIS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE CS/SVC/DF1/RV/SUBQ/SVC
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS061
Date Received06/28/2010
Decision Date11/10/2010
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for implementation of a new release of traceability software.
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