|
Device | BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S035 |
Date Received | 08/21/2006 |
Decision Date | 12/01/2006 |
Product Code |
LPB |
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 ADDITION OF A CHOKE IN THE XP APM WHICH WILL ELIMINATE THE DELIVERY OF THE RF ENERGY WHERE THE USER FAILED TO CONNECT OR IMPROPERLY CONNECTED THE DISPERSIVE INDIFFERENT PATCH (DIP) ELECTRODES TO THE PATIENT. |