|
Device | MULTIPLE APPLICATION UTILITY (MAU) USED WITH ZOOM LATITIDE 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 | S130 |
Date Received | 01/03/2013 |
Decision Date | 02/12/2013 |
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 THE MULTIPLE APPLICATION UTILITY (MAU), SOFTWARE VERSION 8.02. |