Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

ATL Technology CR Limitada

COSTA RICA

3012263546

2026

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Contract Manufacturer

BIOSENSE WEBSTER, INC.

MEXICO

9673241

2026

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - nGEN Pump; SmartAblate Irrigation Tubing Set; SmartAblate RF Generator and Accessories; Sterile Interface Cables for use with the Stockert 70 Radiofrequency Generator; Stockert 70 RF-Generator for Cardiac Ablation

Manufacturer

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Celsius RMT ThermoCool Catheter; Celsius ThermoCool Catheter; EZ Steer ThermoCool Catheter; EZ Steer ThermoCool NAV Catheter; NaviStar RMT ThermoCool Catheter; NAVISTAR THERMOCOOL CATHETER; nGEN Generator; ThermoCool SF Bi-Directional Catheter; ThermoCool SF Catheter; ThermoCool SF NAV Bi-Directional Catheter; ThermoCool SF NAV Catheter; ThermoCool SmartTouch Navigation Catheter; ThermoCool SmartTouch SF Bi-Directional Navigation Catheter; ThermoCool SmartTouch SF Uni-Directional Navigation Catheter; ThermoCool SmartTouch Uni-Directional Ablation Catheter; VISITAG SURPOINT™ EPU

Manufacturer

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Dual Energy THERMOCOOL SMARTTOUCH SF Catheter; OMNYPULSE Catheter; VARIPULSE Catheter

Manufacturer

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - nGEN Generator; QDOT MICRO Catheter; TX eco Cable; TX eco EXT Cable

Manufacturer

BIOSENSE WEBSTER, INC.

CA/USA

3013300026

2026

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Celsius RMT ThermoCool Catheter; Celsius ThermoCool Catheter; EZ Steer ThermoCool Catheter; EZ Steer ThermoCool NAV Catheter; NaviStar RMT ThermoCool Catheter; NAVISTAR THERMOCOOL CATHETER; nGEN Generator; ThermoCool SF Bi-Directional Catheter; ThermoCool SF Catheter; ThermoCool SF NAV Bi-Directional Catheter; ThermoCool SF NAV Catheter; ThermoCool SmartTouch Navigation Catheter; ThermoCool SmartTouch SF Bi-Directional Navigation Catheter; ThermoCool SmartTouch SF Uni-Directional Navigation Catheter; ThermoCool SmartTouch Uni-Directional Ablation Catheter; VISITAG SURPOINT™ EPU

Specification Developer; Complaint File Establishment

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - nGEN Pump; SmartAblate Irrigation Tubing Set; SmartAblate RF Generator and Accessories; Sterile Interface Cables for use with the Stockert 70 Radiofrequency Generator; Stockert 70 RF-Generator for Cardiac Ablation

Specification Developer

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Dual Energy THERMOCOOL SMARTTOUCH SF Catheter; OMNYPULSE Catheter; VARIPULSE Catheter

Manufacturer; Specification Developer; Complaint File Establishment

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - nGEN Generator; QDOT MICRO Catheter; TX eco Cable; TX eco EXT Cable

Specification Developer; Complaint File Establishment

BOSTON SCIENTIFIC CORPORATION

COSTA RICA

3004859241

2026

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - POLARx Cryoablation Balloon Catheter; POLARx FIT Cryoablation Balloon Catheter; SMARTFREEZE Catheter Extension Cable; SMARTFREEZE Cryo-Cable; SMARTFREEZE Cryo-Console; SMARTFREEZE Cryo-Console Foot Switch; SMARTFREEZE Diaphragm Movement Sensor; SMARTFREEZE Inter-Connection Box; SMARTFREEZE Remote Control

Manufacturer

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Blazer Open-Irrigated Ablation Catheter; Cable IntellaTip MiFi OI to Maestro 4000; Cable, IntellaNav Ablation Catheter; Cable, IntellaTip MiFi OI; Cable, Maestro 4000; INTELLAGEN Catheter Adapter Cable 0.3 Meter; INTELLAGEN ECG Connection Cable 3 Meter; INTELLAGEN Foot Pedal; INTELLAGEN Foot Pedal Extension Cable 7 Meter; INTELLAGEN Grounding Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 1 Meter; INTELLAGEN Irrigation Pump Connection Cable 10 Meter; INTELLAGEN Irrigation Pump Connection Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 5 Meter; INTELLAGEN Irrigation Pump Kit; INTELLAGEN Remote Control Connection Cable 10 Meter; INTELLAGEN Remote Control Connection Cable 15 Meter; INTELLAGEN Remote Control Connection Cable 25 Meter; INTELLAGEN Remote Control Connection Cable 30 Meter; INTELLAGEN Remote Control Kit; INTELLAGEN RF Generator Kit; INTELLAGEN Serial Communication Cable 15 Meter; INTELLAGEN Serial Communication Cable 3 Meter; INTELLAGEN Serial Communication Cable 5 Meter; INTELLAGEN Tubing Set; IntellaNav MiFi Open-Irrigated Ablation Catheter; IntellaNav Open-Irrigated Ablation Catheter; IntellaNav StablePoint Ablation Catheter; IntellaNav StablePoint Catheter Cable; IntellaTip MiFi Open-Irrigated Ablation Catheter; MetriQ Foot Switch; MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set; MetriQ Pump Irrigation Pump; Rhythmia HDx Ablation Connection Box - for INTELLAGEN; Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN; RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint; Rhythmia HDx Ablation Connection Box Maestro; Rhythmia Mapping System IntellaNav CB - Maestro

Manufacturer

Boston Scientific Corporation

MN/USA

2124215

2026

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - POLARx Cryoablation Balloon Catheter; POLARx FIT Cryoablation Balloon Catheter; SMARTFREEZE Catheter Extension Cable; SMARTFREEZE Cryo-Cable; SMARTFREEZE Cryo-Console; SMARTFREEZE Cryo-Console Foot Switch; SMARTFREEZE Diaphragm Movement Sensor; SMARTFREEZE Inter-Connection Box; SMARTFREEZE Remote Control

Manufacturer

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Blazer Open-Irrigated Ablation Catheter; Cable IntellaTip MiFi OI to Maestro 4000; Cable, IntellaNav Ablation Catheter; Cable, IntellaTip MiFi OI; Cable, Maestro 4000; INTELLAGEN Catheter Adapter Cable 0.3 Meter; INTELLAGEN ECG Connection Cable 3 Meter; INTELLAGEN Foot Pedal; INTELLAGEN Foot Pedal Extension Cable 7 Meter; INTELLAGEN Grounding Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 1 Meter; INTELLAGEN Irrigation Pump Connection Cable 10 Meter; INTELLAGEN Irrigation Pump Connection Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 5 Meter; INTELLAGEN Irrigation Pump Kit; INTELLAGEN Remote Control Connection Cable 10 Meter; INTELLAGEN Remote Control Connection Cable 15 Meter; INTELLAGEN Remote Control Connection Cable 25 Meter; INTELLAGEN Remote Control Connection Cable 30 Meter; INTELLAGEN Remote Control Kit; INTELLAGEN RF Generator Kit; INTELLAGEN Serial Communication Cable 15 Meter; INTELLAGEN Serial Communication Cable 3 Meter; INTELLAGEN Serial Communication Cable 5 Meter; INTELLAGEN Tubing Set; IntellaNav MiFi Open-Irrigated Ablation Catheter; IntellaNav Open-Irrigated Ablation Catheter; IntellaNav StablePoint Ablation Catheter; IntellaNav StablePoint Catheter Cable; IntellaTip MiFi Open-Irrigated Ablation Catheter; MetriQ Foot Switch; MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set; MetriQ Pump Irrigation Pump; Rhythmia HDx Ablation Connection Box - for INTELLAGEN; Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN; RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint; Rhythmia HDx Ablation Connection Box Maestro; Rhythmia Mapping System IntellaNav CB - Maestro

Manufacturer; Complaint File Establishment

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Establishment Registration & Device Listing

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