|
Device | Epsila EV Extravascular Lead |
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 | S024 |
Date Received | 05/01/2024 |
Decision Date | 05/02/2024 |
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 an update to the cleaning process and solution at a critical supplier of lead components |