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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
Generic NameTESTER, PACEMAKER ELECTRODE FUNCTION
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS013
Date Received02/19/2003
Decision Date07/29/2003
Product Codes DTA DTE KRG LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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