Cardiac Ablation Percutaneous Catheter
Basic Information
- Device Name
- Cardiac Ablation Percutaneous Catheter
- Trade Name
- CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP
- PMA Number
- P980003
- Supplement Number
- S034
- Device Class
- FDA Class 3
- Product Code
- LPB
- Generic Name
- Cardiac ablation percutaneous catheter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 15, 2012
- Date Received
- December 27, 2011
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPB | Cardiac Ablation Percutaneous Catheter | FDA class 3 | Unknown |