|
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 | S074 |
Date Received | 02/23/2007 |
Decision Date | 06/15/2007 |
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 MODEL 6482 RT COMMUNICATOR FOR USE ON THE LATITUDE PATIENT MANAGEMENT SYSTEM. THE MODIFICATIONS INCLUDE A SOFTWARE UPGRADE (VERSION 1.7.0) AND CHANGES TO THE HARDWARE TO INCREASE RF TRANSMIT POWER. |