|
Device | VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S023 |
Date Received | 06/24/1998 |
Decision Date | 07/31/1998 |
Product Code |
LWS |
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 an update to the Model 2881 Software Application to inlcude the DELTA/VISTA pacemakers series, resulting in Version 1.3 of the Model 2881 Software Application. |