|
Device | VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S121 |
Date Received | 05/09/2012 |
Decision Date | 06/19/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE OPTION TO CONNECT THE LATTITUDE COMMUNICATOR TO AN OFF-THE-SHELF COMMERCIALLY AVAILABLE CELLULAR MODEM. |