PMA P010068S075
- Device
- NAVISTAR DS Electrophysiology Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S075
- Product code
- OAD
- Decision date
- 2025-02-25
- Classification
- Cardiovascular
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- an alternate supplier for molded piston components
Current openFDA PMA Record#
- Device
- NAVISTAR DS Electrophysiology Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S075
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2025-02-25
- Decision code
- OK30
- Date received
- 2025-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate supplier for molded piston components