FDA Registration Active 🇨🇷 Costa Rica

TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-J

Reg #: 3008452825 · FEI: 3008452825 · Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Abbott Medical Costa Rica Ltda.
Registration Number
3008452825
FEI Number
3008452825
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol
City
El Coyol Alajuela
Country
CR

Regulatory Submissions

PMA Number
P220013

Owner / Operator

Firm Name
ABBOTT LABORATORIES
Operator Number
1415939
Address
100 ABBOTT PARK RD., D-03Q3, AP52-1
City
Abbott Park
State
IL
Postal Code
60064
Country
US

Products

Device Name Product Code
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

Proprietary Names

TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-J TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-FF TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-FJ TactiSys™ Quartz, TactiFlex™ Radiofrequency Cable, TSQ-RF-TFSE-CBL TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-JJ TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-F TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-DF TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-D TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-DD Ampere™ Generator Ampere™ Generator Kit Ampere™ Remote Control

Establishment Types

Manufacture Medical Device