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 | Aurora EV ICD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Medtronic, Inc. 8200 Coral Sea Street NE MV MVS11 Mounds View, MN 55112 |
PMA Number | P220012 |
Supplement Number | S015 |
Date Received | 02/22/2024 |
Decision Date | 03/11/2024 |
Product Codes |
LWS NVY |
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 to change the supplier for solder bumping of the integrated circuits used in several IPG, CRT-P, ICD, and CRT-D devices |
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