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. |
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Device | ESSENTIO™ SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT™ SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE™ SR, ACCOLADE DR, ACCO |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | N970003 |
Supplement Number | S276 |
Date Received | 09/20/2022 |
Decision Date | 09/27/2022 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implement an automatic handling system for the helium leak test process. |
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