PMA P010068S019
- Device
- NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S019
- Product code
- OAD
- Decision date
- 2010-03-04
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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 DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S019
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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.