|
Device | WEBSTER Catheter / CELSIUS Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S069 |
Date Received | 11/27/2017 |
Decision Date | 03/28/2018 |
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 of transfer of extrusion process for non-braided dual lumen subcomponent catheter part from Cordis Miami to Biosense Webster in Juarez, Mexico. |