PMA P950005S053
- Device
- CELSIUS ELECTROPHYSIOLOGY CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S053
- Product code
- LPB
- Decision date
- 2014-10-21
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ADDITION OF A QUALIFIED SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESSES OF THE CATHETER IN THE DEVICES.
Current openFDA PMA Record#
- Device
- CELSIUS ELECTROPHYSIOLOGY CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S053
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2014-10-21
- Decision code
- OK30
- Date received
- 2014-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A QUALIFIED SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESSES OF THE CATHETER IN THE DEVICES.