PMA P990071S045
- Device
- SmartAblate Irrigation Tubing Set
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S045
- Product code
- LPB
- Decision date
- 2020-10-01
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Update the parameters of an in-process quality control leak test.
Current openFDA PMA Record#
- Device
- SmartAblate Irrigation Tubing Set
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S045
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2020-10-01
- Decision code
- OK30
- Date received
- 2020-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the parameters of an in-process quality control leak test.