PMA P990025S021
- Device
- NAVISTAR RMT
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S021
- Product code
- LPB
- Decision date
- 2009-11-25
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR CHANGES IN LABELING TO REMOVE A STATEMENT EXCLUDING USE WITH THE STEREOTAXIS CARDIODRIVE CATHETER ADVANCEMENT SYSTEM.
Current openFDA PMA Record#
- Device
- NAVISTAR RMT
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S021
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2009-11-25
- Decision code
- APPR
- Date received
- 2009-09-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES IN LABELING TO REMOVE A STATEMENT EXCLUDING USE WITH THE STEREOTAXIS CARDIODRIVE CATHETER ADVANCEMENT SYSTEM.