|
Device | MODEL 3120 ZOOM LATITUDE PROGRAMMER |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S104 |
Date Received | 03/24/2010 |
Decision Date | 05/19/2010 |
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 A MINOR DESIGN CHANGE TO THE MODEL 3120 ZOOM LATITUDE PROGRAMMER AND AN ALTERNATE SUPPLIER FOR THE HARD DRIVE COMPONENT IN THE PROGRAMMER. |