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 | RELIANCE 4-SITE LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S094 |
Date Received | 03/28/2011 |
Decision Date | 09/01/2011 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE TERMINAL TOOL (RENAMED EZ-4 CONNECTOR TOOL), DESIGN CHANGE TO THE LEAD AND TOOL PACKAGING, AND VARIOUS LABELING CHANGES. |
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