- Device
- ThermoCool SmartTouch SF Catheters
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S076
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-01-22
- Decision code
- OK30
- Date received
- 2021-01-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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.