|
Device | EZ Steer Smart Touch; Thermocooll ST Uni |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S059 |
Date Received | 06/30/2017 |
Decision Date | 07/27/2017 |
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 Implementation of the 6-Up Reflow Machine with Recipe Control for Reflow process on all Biosense Webster quad lumen catheter tips at Irwindale |