PMA P950005S064
- Device
- Webster Diag/ Ablation Deflectable Tip Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S064
- Product code
- LPB
- Decision date
- 2017-10-24
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for expansion of manufacturing capacity for extrusion and reflow manufacturing processes.
Current openFDA PMA Record#
- Device
- Webster Diag/ Ablation Deflectable Tip Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S064
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2017-10-24
- Decision code
- APPR
- Date received
- 2017-06-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for expansion of manufacturing capacity for extrusion and reflow manufacturing processes.