PMA P010068

Device: Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)
Applicant: Biosense Webster, Inc.
PMA number: P010068
Supplement: S070
Product code: OAD
Decision date: 2025-02-26
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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: P010068
Supplement: S074
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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