PMA P010068S053
- Device
- Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S053
- Product code
- OAD
- Decision date
- 2017-10-24
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Approval for expansion of manufacturing capacity for extrusion and reflow manufacturing processes.
Current openFDA PMA Record#
- Device
- Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S053
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-10-24
- Decision code
- APPR
- Date received
- 2017-06-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for expansion of manufacturing capacity for extrusion and reflow manufacturing processes.