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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 NameATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS007
Date Received06/28/2002
Decision Date12/23/2002
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study for the device.
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