|
Device | EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S076 |
Date Received | 01/25/2005 |
Decision Date | 03/01/2005 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR. |