PMA P950005S044
- Device
- EZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THERMOCOUPLE, 7F EZ NON-NAV CATHETER W/4MM TIP ELECTRODE AND THERMISTOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S044
- Product code
- LPB
- Decision date
- 2013-05-29
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
Current openFDA PMA Record#
- Device
- EZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THERMOCOUPLE, 7F EZ NON-NAV CATHETER W/4MM TIP ELECTRODE AND THERMISTOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S044
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2013-05-29
- Decision code
- OK30
- Date received
- 2013-04-26
- Supplement type
- 30-Day Notice
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.