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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.
 
DeviceEssentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberN970003
Supplement NumberS245
Date Received11/22/2019
Decision Date11/27/2019
Product Code LWP 
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  
Replace the current Automated Optical Inspection equipment system and to update the inspection process.
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