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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 PCD TACHYARRHYTHMIA CONTROL SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS018
Date Received08/10/1995
Decision Date11/29/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of an alternate sterilization process and a modification to the distal end of the transvene leads.
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