|
Device | EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T |
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 | S072 |
Date Received | 03/22/2004 |
Decision Date | 04/09/2004 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE USE OF TANTALUM CAPACITORS IN EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T PULSE GENERATORS (P910023/S072) AND THE MODEL 3307 PROGRAMMER SOFTWARE V 4.6M (P830045/S091 AND P880086/S099). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T AND MODEL 3307 PROGRAMMER SOFTWARE V 4.6M. |