|
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 | S094 |
Date Received | 05/26/2009 |
Decision Date | 07/21/2009 |
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 OF A SOFTWARE MAINTENANCE RELEASE (SMR) FOR THE LATITUDE SYSTEM SERVER SOFTWARE, V5.0.6, MODEL 6488. |