PMA P030031S057
- Device
- EZ STEER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S057
- Product code
- LPB
- Decision date
- 2013-10-09
- 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
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S057
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2013-10-09
- Decision code
- OK30
- Date received
- 2013-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.