PMA P950005S088
- Device
- Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S088
- Product code
- LPB
- Decision date
- 2025-02-26
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Sterilization Chamber Addition and Processing Specification Change for production of cables
Current openFDA PMA Record#
- Device
- Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S088
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- 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