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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.
 
DeviceKENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18
Classification Nametester, pacemaker electrode function
Generic Nametester, pacemaker electrode function
Regulation Number870.3720
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP980023
Supplement NumberS013
Date Received02/19/2003
Decision Date07/29/2003
Product Code
DTA[ Registered Establishments with DTA ]
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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