CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

FDA premarket approval P980003/S034 · decided 2012-02-15

Approval details

PMA number

P980003

Supplement

S034

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

Generic name

Cardiac ablation percutaneous catheter

Applicant

Boston Scientific Corp

Date received

2011-12-27

Decision date

2012-02-15

Days to decision

50 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

San Jose, CA

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

510(k) clearances by this applicant