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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.
 
DeviceMaestro 4000 Controller Firmware
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS090
Date Received08/09/2019
Decision Date08/23/2019
Withdrawal Date02/28/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Update Maestro 4000 Controller FW from version 5.14 to version 5.23 (market approved) in the field.
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