PMA P210027S014
- Device
- TX eco EXT Cable
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S014
- Product code
- OAE
- Decision date
- 2025-02-26
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Sterilization Chamber Addition and Processing Specification Change for production of cables
Current openFDA PMA Record#
- Device
- TX eco EXT Cable
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S014
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2025-02-26
- Decision code
- OK30
- Date received
- 2024-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Sterilization Chamber Addition and Processing Specification Change for production of cables