PMA P010068S032
- Device
- CELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S032
- Product code
- OAD
- Decision date
- 2013-07-22
- 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 THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- CELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S032
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2013-07-22
- Decision code
- APPR
- Date received
- 2013-03-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.