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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 Low Voltage Active
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP140033
Supplement NumberS044
Date Received11/30/2018
Decision Date12/17/2018
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  
Acquire curing trays and Teflon coating services from alternate suppliers for use in the curing process when creating Optim E2A resin pellets.
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