PMA P010068S039
- Device
- CELSIUS DS CATHETER, NAVISTAR DS CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S039
- Product code
- OAD
- Decision date
- 2014-07-02
- 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 APPLYING A CHANGE IN STERILIZATION RELEASE METHOD TO THE NEW LINE OF CATHETERS AT THE SANTA TERESA, NEW MEXICO FACILITY.
Current openFDA PMA Record#
- Device
- CELSIUS DS CATHETER, NAVISTAR DS CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S039
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2014-07-02
- Decision code
- APPR
- Date received
- 2014-04-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR APPLYING A CHANGE IN STERILIZATION RELEASE METHOD TO THE NEW LINE OF CATHETERS AT THE SANTA TERESA, NEW MEXICO FACILITY.