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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.
 
DeviceVercise Deep Brain Stimulation (DBS) Systems
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS079
Date Received11/18/2024
Decision Date12/18/2024
Product Code NHL 
Advisory Committee Neurology
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  
to add an alternative Macro Laser Weld system to the existing Laser Weld system for the creation of a weld seam around the case half seam and feedthru and case of WaveWriter Alpha and Vercise Genus Implantable Pulse Generator (IPG} devices at the Boston Scientific Corp. Clonmel manufacturing site
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