|
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 | S051 |
Date Received | 03/15/2005 |
Decision Date | 09/08/2005 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM INCLUDING THE MODEL 6482 LATITUDE COMMUNICATOR V1.4 AND THE SUPPLEMENTAL APPLICATION SERVER (SAS) SOFTWARE V1.0.1 FOR USE IN MONITORING PATIENTS IMPLANTED WITH A CONTAK RENEWAL 3 RF. |