|
Device | MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S046 |
Date Received | 09/01/2004 |
Decision Date | 02/10/2005 |
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 MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM. THE MODEL 3120 PRM IS INTENDED TO BE USED AS A COMPLETE SYSTEM TO COMMUNICATE WITH GUIDANT IMPLANTABLE PULSE GENERATORS. THE SOFTWARE IN USE CONTROLS ALL COMMUNICATION FUNCTIONS FOR THE PULSE GENERATOR. FOR DETAILED SOFTWARE APPLICATION INSTRUCTIONS, REFER TO THE SYSTEM GUIDE FOR THE GUIDANT PULSE GENERATOR BEING INTERROGATED. |