PMA P990025S028
- Device
- NAVISTAR/RMT/EZ STEER NAV/QWIKSTAR/INTERFACE CABLES
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S028
- Product code
- LPB
- Decision date
- 2011-04-06
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ADDITION OF A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS.
Current openFDA PMA Record#
- Device
- NAVISTAR/RMT/EZ STEER NAV/QWIKSTAR/INTERFACE CABLES
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S028
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2011-04-06
- Decision code
- OK30
- Date received
- 2011-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS.