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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
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 study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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