|
Device | Navistar Thermocool Deflectable Diagnostics/Ablation Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S058 |
Date Received | 06/02/2017 |
Decision Date | 10/24/2017 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for expansion of manufacturing capacity for extrusion and reflow manufacturing processes. |