|
Device | CHILLI COOLED ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S025 |
Date Received | 10/18/2010 |
Decision Date | 04/08/2011 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TEN DESIGN CHANGES TO THE CIRCUCOOL MODEL 8005 PUMP SYSTEM TO ADDRESS STOPPAGE AND MOTOR NOISE COMPLAINTS. THESE CHANGES INCLUDE: 1) CHANGING A SCHOTKY DIODE FROM ON SEMICONDUCTOR¿S 1N5822 (40V MAXIMUM REVERSE VOLTAGE) TO ON SEMICONDUCTOR¿S MBR360 (60V MAXIMUM REVERSE VOLTAGE). 2) ADDITION OF A 33.3V VOLTAGE SUPPRESSOR (ON SEMICONDUCTOR P6KE39AG) ACROSS MOTOR TERMINALS AT THE MOTOR. 3) DIMENSIONAL AND TOLERANCE REVISIONS TO THE ROLLER SLEEVE, SHAFT ROTOR AND ROLLER COMPONENTS. |