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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 NumberS003
Date Received05/12/2017
Decision Date06/08/2017
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of a 100% in-line inspection for gel lumps in the body tubing of the Myopore lead.
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