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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.
Classification Nameimplantable pulse generator, pacemaker (non-crt)
PMA NumberP010015
Supplement NumberS003
Date Received11/19/2001
Decision Date05/02/2002
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the attain otw 4193 left ventricular pacing lead. The model 4193 is indicated for use as part of a medtronic biventricular pacing system.