PMA P990025S012
- Device
- NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S012
- Product code
- LPB
- Decision date
- 2006-10-06
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR USING A NEW HANDLE, PULLER WIRES AND 1 MM LOCATION SENSOR.
Current openFDA PMA Record#
- Device
- NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S012
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2006-10-06
- Decision code
- APPR
- Date received
- 2006-06-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USING A NEW HANDLE, PULLER WIRES AND 1 MM LOCATION SENSOR.