|
Device | LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S087 |
Date Received | 05/23/2008 |
Decision Date | 06/26/2008 |
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 CHANGE TO THE LATITUDE COMMUNICATOR SOFTWARE MODEL 6482), VERSIONS 1.8 AND 2.2, AND THE LATITUDE INDUCTIVE COMMUNICATOR SOFTWARE (MODEL 6481) VERSION 1.4. |