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Device | LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481 SOFTWARE, VERSION 1.6. |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S109 |
Date Received | 09/24/2010 |
Decision Date | 11/19/2010 |
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 MODIFICATIONS TO THE SOFTWARE FOR THE LATITUDE INDUCTIVE COMMUNICATOR (MODEL 6481). |