PMA P950005S057
- Device
- CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ELECTROPHYSIOLOGY CATHETER,
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S057
- Product code
- LPB
- Decision date
- 2015-06-02
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ACCEPTANCE OF A SUPPLIER MANUFACTURING SITE CHANGE FOR VACUUM-FORMED PLASTIC TRAY COMPONENTS.
Current openFDA PMA Record#
- Device
- CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ELECTROPHYSIOLOGY CATHETER,
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S057
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2015-06-02
- Decision code
- OK30
- Date received
- 2015-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ACCEPTANCE OF A SUPPLIER MANUFACTURING SITE CHANGE FOR VACUUM-FORMED PLASTIC TRAY COMPONENTS.