Premarket Approval (PMA)

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.

• Device: Myopore Sutureless Myocardial Pacing Lead
• Generic Name: permanent pacemaker Electrode
• Regulation Number: 870.3680
• Applicant: Great Batch Medical; 2300 Berkshire Ln. N.; Plymouth, MN 55441
• PMA Number: P130012
• Supplement Number: S005
• Date Received: 08/27/2018
• Decision Date: 09/25/2018
• Product Code: DTB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Modification of the manufacturing location of an existing component supplier.