Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ThermoCool SmartTouch SF Catheters |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S076 |
Date Received | 01/07/2021 |
Decision Date | 01/22/2021 |
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 Transfer the extrusion process for the Quad Lumen Core subcomponent from the Biosense Webster Inc. Irwindale, CA facility to the Biosense Webster, Inc. Juarez, MX facility. |
|
|