|
Device | ThermoCool SmartTouch Uni-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 | S060 |
Date Received | 08/08/2017 |
Decision Date | 02/02/2018 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the THERMOCOOL SMARTTOUCH Catheter Instructions for Use to align with the safety information in the THERMOCOOL SMARTTOUCH SF Catheter Instructions for Use. |