|
Device | CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S034 |
Date Received | 12/27/2011 |
Decision Date | 02/15/2012 |
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 FIVE CHANGES TO ADDRESS THE FAILURE OF A MICRO SWITCH DESIGNED TO AUTOMATICALLY SHUT OFF THE PUMP IF THE ROLLER BED COVER IS OPENED WITHOUT TURNING OFF THE POWER SWITCH. THESE CHANGES INCLUDE: 1) INTRODUCING A NEW MICRO SWITCH WHICH FEATURES AN AUXILIARY ACTUATOR WHICH ELIMINATES DIRECT CONTACT BETWEEN THE RETAINER SCREW AND THE ACTUATOR BUTTON; 2) ADDING A SECONDARY SHOULDER ON THE RETAINER SCREW TO LIMIT THE SCREW PENETRATION DEPTH TO COINCIDE WITH THE TOLERANCE STACK UP WITH THE MICRO SWITCH POSITION; 3) MINOR DIMENSION AND TOLERANCE CHANGES TO THE MOUNTING PLATE TO ACCOMMODATE THE NEW MICRO SWITCH; 4) USE COUNTER-SINK HOLES INSTEAD OF STRAIGHT-THROUGH HOLES IN THE PUMP HEAD TO SECURE THE MOUNTING PLATE, ENSURING BRACKET ALIGNMENT AND MINIMIZING PLAY IN THE BRACKET INSTALLATION; AND 5) ADDING AN INSPECTION STEP AND TEST FIXTURE TO VERIFY THE INSTALLED POSITION OF THE MICRO SWITCH RELATIVE TO THE PUMP HEAD. |