|
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 | S097 |
Date Received | 09/30/2009 |
Decision Date | 11/25/2009 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM G2 RF COMMUNICATOR MODEL 6476 SOFTWARE, VERSION 3.02 AND LATITUDE PATIENT MANAGEMENT SERVER MODEL 6488, VERSION 5.2. |