PMA P990025S030
- Device
- EZ STEER NAV ELECTROPHYSIOLOGY CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S030
- Product code
- LPB
- Decision date
- 2012-03-30
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- CHANGE IN CALIBRATION AND CALIBRATION CHECK MANUFACTURING PROCESSES PI-008-01 AND PI-008-02 TO INCORPORATE THE CATHETER CALIBRATION SYSTEM AS AN ALTERNATIVE TO THE HELMHOLTZ CALIBRATION SYSTEM.
Current openFDA PMA Record#
- Device
- EZ STEER NAV ELECTROPHYSIOLOGY CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S030
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2012-03-30
- Decision code
- OK30
- Date received
- 2012-03-02
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN CALIBRATION AND CALIBRATION CHECK MANUFACTURING PROCESSES PI-008-01 AND PI-008-02 TO INCORPORATE THE CATHETER CALIBRATION SYSTEM AS AN ALTERNATIVE TO THE HELMHOLTZ CALIBRATION SYSTEM.