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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 4193 ATTAIN OTW LEAD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS010
Date Received04/08/2003
Decision Date05/09/2003
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for material and labeling changes for various medtronic and vitatron pacing and defibrillator leads.
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