PMA P950005S061
- Device
- WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S061
- Product code
- LPB
- Decision date
- 2017-08-10
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for a material change to the adhesive mixture used in the manufacture of BWI catheters and cables.
Current openFDA PMA Record#
- Device
- WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S061
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2017-08-10
- Decision code
- APPR
- Date received
- 2016-06-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a material change to the adhesive mixture used in the manufacture of BWI catheters and cables.