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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.
 
DeviceMyopore® Sutureless Myocardial Pacing Lead
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantGreat Batch Medical
2300 Berkshire Ln. N.
Plymouth, MN 55441
PMA NumberP130012
Supplement NumberS013
Date Received01/26/2023
Decision Date02/07/2023
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes being effected (CBE) to include revisions and enhancements to the content in the Myopore lead Instructions for Use manual and packaging labeling.
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