PMA P030031S032
- Device
- CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S032
- 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
- CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S032
- 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.