PMA P010068S029
- Device
- NAVISTAR/CELSIUS DS CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S029
- Product code
- OAD
- Decision date
- 2012-07-25
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- ALTERNATE SUPPLIER OF THE CONDUCTOR CABLE COMPONENT.
Current openFDA PMA Record#
- Device
- NAVISTAR/CELSIUS DS CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S029
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2012-07-25
- Decision code
- OK30
- Date received
- 2012-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIER OF THE CONDUCTOR CABLE COMPONENT.