- Device
- SmartAblate Irrigation Tubing Set and nGEN Pump
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S054
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2022-06-08
- Decision code
- OK30
- Date received
- 2022-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the location for inspection of the SmartAblate Irrigation Tubing Set and nGEN Pump from the Irwindale, CA site to the Irvine, CA site.