PMA P990025S023
- Device
- NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S023
- Product code
- LPB
- Decision date
- 2010-03-04
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE MU-SHIELD USED IN THE MANUFACTURE OF THE NAVIGATIONAL CATHETERS.
Current openFDA PMA Record#
- Device
- NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S023
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2010-03-04
- Decision code
- OK30
- Date received
- 2010-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE MU-SHIELD USED IN THE MANUFACTURE OF THE NAVIGATIONAL CATHETERS.