PMA P990025S014
- Device
- QUIKSTAR FAMILY OF CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S014
- Product code
- LPB
- Decision date
- 2007-10-29
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.
Current openFDA PMA Record#
- Device
- QUIKSTAR FAMILY OF CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S014
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2007-10-29
- Decision code
- OK30
- Date received
- 2007-10-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.