PMA P950005S048
- Device
- BIOSENSE WEBSTER CELSIUS FLTR CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S048
- Product code
- LPB
- Decision date
- 2013-11-26
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- CHANGE TO THE OVEN PARAMETERS IN THE TIP REFLOW PROCESS AND IMPLEMENTATIONOF A NEW INSPECTION.
Current openFDA PMA Record#
- Device
- BIOSENSE WEBSTER CELSIUS FLTR CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S048
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2013-11-26
- Decision code
- OK30
- Date received
- 2013-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE OVEN PARAMETERS IN THE TIP REFLOW PROCESS AND IMPLEMENTATIONOF A NEW INSPECTION.