PMA P990025S039
- Device
- NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S039
- Product code
- LPB
- Decision date
- 2014-01-24
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
Current openFDA PMA Record#
- Device
- NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S039
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2014-01-24
- Decision code
- OK30
- Date received
- 2013-12-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.