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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.
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nameimplantable pulse generator
PMA NumberP980035
Supplement NumberS270
Date Received08/23/2012
Decision Date02/19/2013
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling updates to incorporate the results of the respect post approval study final report, and additional labeling updates.