|
Device | LATITUDE PATIENT MANAGEMENT SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S068 |
Date Received | 01/11/2007 |
Decision Date | 03/23/2007 |
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 |
Approval Order Statement APPROVAL FOR SOFTWARE UPDATES TO 1) CHANGE THE CURRENT WEIGHT ALERT ALGORITHM TO REDUCE OVER-REPORTING OF WEIGHT ALERTS; AND 2) TO CORRECT A DETECTION FAILURES DUE TO DIFFERING TIME ZONE CHANGES. |