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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2023-05-19 |
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