|
Device | ThermoCool SmartTouch Uni-directional and ThermoCool SmartTouch Bi-directional navigation Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S067 |
Date Received | 04/10/2019 |
Decision Date | 04/19/2019 |
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 semi-automated prep shaft machine as an alternate manufacturing process for the ThermoCool SmartTouch and ThermoCool SmartTouch SF catheters. |