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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 NumberS009
Date Received08/05/2022
Decision Date10/05/2022
Product Code DTB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implement a revised sterilization parameter for Myopore products in an effort to reduce the EO emission.
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