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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.
 
DeviceTendril MRI Steroid Eluting Cardiac Leads
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP140033
Supplement NumberS045
Date Received05/01/2019
Decision Date05/29/2019
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Manufacturing process improvements for monolithic controlled release devices used in Tendril MRI1200M leads.
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