PMA P010068S030
- Device
- CELSIUS DS CATHETER AND NAVI-STAR DS CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S030
- Product code
- OAD
- Decision date
- 2012-10-24
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUDING AND BRAIDING PROCESS.
Current openFDA PMA Record#
- Device
- CELSIUS DS CATHETER AND NAVI-STAR DS CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S030
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2012-10-24
- Decision code
- OK30
- Date received
- 2012-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUDING AND BRAIDING PROCESS.