|
Device | ThermoCool Smart Touch SF Catheters |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S062 |
Date Received | 12/14/2017 |
Decision Date | 01/11/2018 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Add a rework process for the ThermoCool SmartTouch and ThermoCool SmartTouch SF catheters to correct an incorrect calibration. |