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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.
 
DevicePG ACCOLADE DR, PG ACCOLADE SR, PG ALTRUA 2 DR, PG ALTRUA 2 SR, PG ESSENTIO DR, PG ESSENTIO SR, PG PROPONENT DR, and PG
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberN970003
Supplement NumberS257
Date Received10/01/2020
Decision Date10/22/2020
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  
Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.
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