PMA P210027S017
- Device
- TX eco Cable
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S017
- Product code
- OAE
- Decision date
- 2026-08-17
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- relocation of manufacturing line within the existing manufacturing facility
Current openFDA PMA Record#
- Device
- TX eco Cable
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S017
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-08-17
- Decision code
- OK30
- Date received
- 2026-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- relocation of manufacturing line within the existing manufacturing facility