PMA P990071S050
- Device
- Smartablate System Interface Cables
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S050
- Product code
- LPB
- Decision date
- 2021-07-09
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Addition of an electronic vision sensor to the device packaging process.
Current openFDA PMA Record#
- Device
- Smartablate System Interface Cables
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S050
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-07-09
- Decision code
- OK30
- Date received
- 2021-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an electronic vision sensor to the device packaging process.