- Device
- SmartAblate Irrigation Tubing Set
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S053
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2022-03-15
- Decision code
- OK30
- Date received
- 2022-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of quality inspection for the SmartAblate Irrigation Tubing Set from BWI Irwindale to Venusa De Mexico S. De R.L De C.V, DBA Lake Region Medical (LRM), a previously approved supplier.