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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 NumberS010
Date Received08/08/2022
Decision Date12/12/2022
Product Code DTB 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a supplier site change and subsequent manufacturing process changes.
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