|
Device | LATITUDE WAVE COMMUNICATOR (MODEL 6498) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S119 |
Date Received | 02/09/2012 |
Decision Date | 01/28/2013 |
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 |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE LATITUDE WAVE COMMUNICATOR AND SYSTEM SOFTWARE LATITUDE NXT SOFTWARE FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM. |
Approval Order | Approval Order |